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AstraZeneca/Merck’s Lynparza Is First Adjuvant Option For BRCA-Positive Breast Cancer

 
• By Joseph Haas

One of two PARP inhibitors approved in breast cancer, Lynparza may have the adjuvant breast indication all to itself for a while. One analyst projects a $1.5bn revenue opportunity for the indication.

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AstraZeneca plants flag with first adjuvant option for BRCA+ breast cancer • Source: Alamy

AstraZeneca PLC and partner Merck & Co., Inc. have added a first-in-class indication to PARP inhibitor Lynparza’s (olaparib) US label, making the drug the first approved adjuvant therapy for early, high-risk breast cancer patients with BRCA mutations.

One of two PARP inhibitors approved in breast cancer – along with Pfizer Inc.’s Talzenna (talazoparib) – Lynparza is...

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Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

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UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

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Top 10 Drugs Q1 2025: Keytruda Dominates; Mounjaro Climbs

 
• By Eleanor Malone

Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.

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BIO Notebook: MFN Pricing, Next-Gen Obesity R&D, FDA’s Rare Disease Hub & Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.