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NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
The National Institute for Health and Care Excellence (NICE) has recommended amivantamab (Rybrevant) plus lazertinib (Lazcluze) as a first-line option for adults with previously untreated advanced non–small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
In final draft guidance, NICE said the combination therapy should be funded by the NHS in England for eligible patients when it is the most appropriate option. Around 1115 people are expected to benefit.
Lung cancer is the third most common cancer and the leading cause of cancer mortality in the UK. It accounted for 10% of all new cancer diagnoses and 20% of cancer deaths in 2020. Approximately 31,000 people received NSCLC diagnoses in England in 2021, comprising 91% of all lung cancer cases. EGFR mutation-positive NSCLC is more common in women, non-smokers, and individuals from Asian ethnic backgrounds.
Welcoming the decision, Virginia Harrison, research trustee, EGFR+ UK, said, “This is a meaningful advance for patients and their families facing this diagnosis. [It] provides something the EGFR community urgently needs: more choice in first-line treatment.”
How Practice May Shift
The recommendation adds an alternative to existing standards, including osimertinib monotherapy or osimertinib plus pemetrexed/platinum-based chemotherapy. Clinical specialists noted that no single standard care exists for this patient group.
Younger patients and those willing to accept greater side effects may choose between amivantamab plus lazertinib or osimertinib plus chemotherapy. Patients older than 80 years might prefer osimertinib monotherapy due to adverse event considerations.
Mechanism of Action and Clinical Evidence
Amivantamab is a bispecific antibody that simultaneously binds EGFR and mesenchymal-epithelial transition receptors, blocking downstream signaling pathways that drive tumor growth and promoting immune-mediated cancer cell killing. Lazertinib is an oral third-generation EGFR TKI that selectively inhibits mutant EGFR signaling. Together, the agents provides complementary suppression of EGFR-driven tumour growth and resistance mechanisms.
The NICE recommendation is supported by results from the phase 3 MARIPOSA trial, which met its primary endpoint of progression-free survival (PFS). Treatment with amivantamab plus lazertinib significantly prolonged median PFS to 23.7 months compared with 16.6 months with osimertinib. The combination also demonstrated a significant improvement in overall survival, reducing the risk for death by 25% vs osimertinib. Median OS was not reached in the combination arm and was 36.7 months with osimertinib.
The most common adverse reactions with the combination included rash, nail toxicity, hypoalbuminaemia, hepatotoxicity, and stomatitis.
A Medicines and Healthcare products Regulatory Agency-approved subcutaneous formulation of amivantamab, authorized after the committee’s initial meeting, may further improve tolerability and convenience. Administration-related reactions occurred in 63% of patients with the intravenous formulation vs 14% with the subcutaneous formulation. Clinicians expect subcutaneous dosing to replace intravenous use in practice.
Dosing, Access, and Implementation
Amivantamab is administered every 2 weeks, either intravenously or subcutaneously. Lazertinib is taken as a daily oral tablet.
Rybrevant costs £1079 for a 350-mg per 7-mL vial. Lazcluze is priced at £4128.50 for 56 x 80-mg tablets and £6192.75 for 28 x 240-mg tablets. Confidential NHS discounts are available through simple patient access schemes.
Integrated care boards, NHS England, and local authorities must implement the guidance within 90 days of publication. For drugs receiving positive draft recommendations for routine commissioning, interim funding becomes accessible from the Cancer Drugs Fund budget starting from the point of marketing authorisation or publication of draft guidance.
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
NICE Endorses Chemo-Free First-Line Options for EGFR NSCLC
NICE Endorses Oral Alternative to Chemo in Prostate Cancer
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
A faster, oral alternative to docetaxel is set to reach NHS clinics after the National Institute for Health and Care Excellence (NICE) recommended darolutamide (Nubeqa, Bayer) in combination with androgen deprivation therapy (ADT) for men with metastatic hormone-sensitive prostate cancer who are unable to receive or tolerate chemotherapy.
Detailed in NICE’s final draft guidance, the decision will make darolutamide available through the NHS in England and Wales to approximately 6000 patients, offering a new oral therapy for those who with limited alternatives to docetaxel or other androgen-receptor inhibitors.
New Option for Chemo-Ineligible Patients
Darolutamide functions by blocking hormones that fuel cancer growth, specifically depriving prostate cancer cells of testosterone required for multiplication and spread. Patients take two tablets twice daily alongside standard ADT.
Peter Johnson, national clinical director for cancer at NHS England, welcomed the decision and expects this approval to give clinicians and their patients “more flexibility to choose the approach best suited to individual circumstances and clinical needs.”
The guidance was finalised 5 weeks ahead of the standard review timeline, underscoring NICE’s commitment to accelerating access to effective prostate cancer treatments.
Clinical Trial Evidence
The NICE’s decision was supported by evidence from the phase 3 ARASENS trial (N = 1306).
The results showed that adding darolutamide to ADT and docetaxel significantly improved overall survival in metastatic hormone-sensitive prostate cancer, reducing the risk for death by 32% compared with ADT and docetaxel alone. Progression-free outcomes, measured by time to castration-resistant disease or death, also favoured darolutamide.
A NICE network meta-analysis of the TITAN, ARCHES, LATITUDE, and STAMPEDE trials suggested that combining ADT with androgen-receptor pathway inhibitors such as apalutamide, enzalutamide, and abiraterone provides comparable survival benefits in this disease setting.
Cost and Implementation
NICE determined that darolutamide plus ADT delivers similar or lower overall costs to the NHS compared with apalutamide plus ADT. The list price is £4040.00 for a 28-day supply (112 × 300-mg tablets), though Bayer has agreed to a confidential commercial discount.
The guidance requires healthcare providers to use the least expensive suitable treatment option, considering administration costs, dosages, price per dose, and commercial arrangements when choosing between darolutamide plus ADT and apalutamide plus ADT.
NHS England and integrated care boards must provide funding within 30 days of final publication, with routine commissioning beginning after this interim period.
A version of this article first appeared on Medscape.com.
First Brain-Injected Gene Therapy Approved by FDA
The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.
AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises.
Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.
The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.
Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections.
A version of this article appeared on WebMD.com.
The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.
AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises.
Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.
The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.
Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections.
A version of this article appeared on WebMD.com.
The US Food and Drug Administration (FDA) has granted fast-track approval for a groundbreaking gene therapy indicated for a rare genetic disorder called aromatic L-amino acid decarboxylase (AADC) deficiency. The gene therapy, marketed under the brand name Kebilidi, is the first in the United States to be injected directly into the brain. It is approved for children with fully developed skulls and for adults.
AADC is an enzyme that helps the body make dopamine. AADC deficiency affects patients’ physical, mental, and behavioral health from infancy, leading to severe disabilities and shorter lifespan. Children with AADC may also experience painful seizure-like episodes called oculogyric crises.
Kebilidi (generic name: eladocagene exuparvovec) is injected into a specific area of the brain where it boosts AADC, restoring dopamine production and gradually improving movement-related symptoms. This surgery is to be performed only by brain surgeons in specialized centers.
The FDA approval was based on the therapy’s safety and effectiveness as shown in an ongoing clinical trial involving 13 children diagnosed with AADC deficiency. According to PTC Therapeutics, the maker of Kebilidi, long-term follow-up studies of the participants are still needed, and additional proof of the therapy’s benefits are required for full FDA approval.
Common side effects of Kebilidi therapy may include involuntary movements (dyskinesia), anemia, fever, low blood pressure, excessive salivation, problems sleeping, low blood levels of certain minerals, and complications after the injection, including breathing or heart problems. The surgical procedure for injecting Kebilidi also carries certain risks, such as cerebrospinal fluid leaks, bleeding in the brain, inflammation, strokes, and infections.
A version of this article appeared on WebMD.com.
FDA OKs New Drug for Urinary Tract Infections
The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.
Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.
Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.
Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs.
“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.
The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.
The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.
Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.
Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.
Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs.
“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.
The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.
The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration (FDA) has approved Orlynvah, a new oral treatment for uncomplicated urinary tract infections (UTIs) in women who have limited options for effective antibiotic therapy.
Uncomplicated UTIs are bladder infections that typically affect women who don’t have other issues like kidney disease or urinary tract abnormalities. These infections are common, affecting around half of all women at least once in their lives.
Treating UTIs can be difficult when standard antibiotics don’t work well, often because of antibiotic resistance or certain health conditions. Orlynvah offers a promising new option by combining two drugs, sulopenem etzadroxil and probenecid, in one oral tablet. This combination helps keep the antibiotic in the body longer, making it work better, especially against bacteria that resist traditional treatments. Orlynvah is specifically approved to target infections from bacteria like Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis, which can be harder to treat.
Marjorie Golden, MD, an infectious disease specialist at Yale New Haven Hospital in Connecticut, described Orlynvah as a much-needed alternative for women struggling with difficult-to-treat UTIs.
“Orlynvah has the potential to be an important treatment option for those who need it,” she said in a news release from Iterum Therapeutics, the drug’s maker.
The FDA approved Orlynvah based on two large clinical trials involving over 3,800 women. In these studies, Orlynvah worked as well as or better than antibiotics like ciprofloxacin and Augmentin. It was generally well-tolerated, though common side effects included diarrhea, nausea, yeast infections, and headaches.
The FDA advises people to discuss their medical history with their doctor before taking Orlynvah, especially if they have conditions like gout, kidney stones, or allergies to other antibiotics.
A version of this article first appeared on Medscape.com.