INSTITUT CLAUDIUS REGAUD
🇫🇷France
Breakthrough Breast Cancer Drug Capivasertib Approved for NHS Use
• A groundbreaking twice-daily pill called capivasertib (Truqap) has been approved for NHS use, targeting hormone receptor-positive HER2-negative breast cancer by blocking cancer growth mechanisms.
• Clinical trials demonstrated the drug extends time before cancer progression by over four months when used alongside hormone therapy Fulvestrant, offering new hope for approximately 3,000 women annually.
• The treatment specifically benefits patients with PIK3CA, AKT1 or PTEN gene mutations, allowing many to maintain good quality of life with fewer debilitating side effects compared to other treatment regimens.
Retifanlimab Plus Chemotherapy Shows Promise in Advanced Squamous Cell Anal Carcinoma
• Phase 3 POD1UM-303 trial shows retifanlimab combined with chemotherapy significantly improves progression-free survival in patients with locally recurrent or metastatic squamous cell anal carcinoma (SCAC).
• The combination therapy demonstrated a median PFS of 9.3 months compared to 7.4 months with chemotherapy alone, marking a potential new standard of care.
• Interim overall survival data also suggest a trend towards improvement with the addition of retifanlimab, with manageable immune-related adverse effects.
• The study's success supports a planned supplemental biologics license application (sBLA) for retifanlimab, offering hope for addressing unmet needs in SCAC treatment.
Olaparib Shows Sustained Benefit in Early-Stage BRCA-Mutated Breast Cancer
• Olaparib improves long-term survival in women with high-risk, early-stage breast cancer and BRCA1/2 mutations, reducing cancer recurrence risk by 35%.
• After six years, 87.5% of olaparib-treated patients were alive, compared to 83.2% in the placebo group, demonstrating a significant survival advantage.
• The OlympiA trial reinforces the importance of BRCA testing to identify patients who can benefit from personalized olaparib treatment early.
• Olaparib is now recommended by NICE in England and Wales for early-stage, high-risk breast cancer with BRCA1/2 mutations, improving survival chances.
FDA Approves Ziihera (zanidatamab-hrii) for HER2-Positive Biliary Tract Cancer
• The FDA granted accelerated approval to Ziihera (zanidatamab-hrii) for previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC).
• Approval was based on a 52% objective response rate and 14.9 months median duration of response in the HERIZON-BTC-01 trial.
• Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S., offering a new treatment option.
• Zymeworks will receive a $25M milestone payment from Jazz Pharmaceuticals and is eligible for up to $500M in regulatory milestones.
NICE Rejects AstraZeneca's Lynparza for Prostate Cancer Despite Scottish Approval
• NICE has issued draft guidance rejecting Lynparza (olaparib) for routine NHS use in treating metastatic prostate cancer with BRCA1/2 mutations, citing uncertain evidence and cost-effectiveness concerns.
• The decision creates a treatment disparity across the UK, as Scotland approved Lynparza for prostate cancer in September, highlighting regional differences in drug access.
• At £2,317.50 per pack with an average treatment course costing £37,491, NICE determined that AstraZeneca's economic model failed to demonstrate sufficient benefit to justify the price.
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