Keeping Track: US FDA Set For Speed With Approvals Of Inqovy, Rukobia, Dojolvy, Phesgo; Keytruda Loses Chance At AA In HCC
The latest drug development news and highlights from the Pink Sheet’s FDA Performance Tracker.
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Roche debuts ‘responsibly priced’ Phesgo in India. Will the dramatic reduction in treatment time for women with HER2 positive breast cancer and other benefits, including insurance coverage, trigger sharp shifts towards the subcutaneous fixed-dose combination of Perjeta and Herceptin?
Agenus was banking on US FDA taking the full six months to act on Keytruda application in same cervical cancer indication where it was seeking accelerated approval; agency took less than two months, making it among the fastest oncology supplemental approvals in the last two years.
Solid tumor-focused Taiho Oncology teams with hematological cancer specialist Astex under the Otsuka umbrella. Taiho also performs US/Canada commercialization for all three firms.