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Keeping Track: US FDA Approves Koselugo, Bestows BTDs On Bavencio, Sotatercept

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The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.

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Fresh Win For AstraZeneca/Merck & Co Pact With Koselugo Approval

Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.

Pfizer Oncology Pipeline Shows Pivot To Targeted Therapies

Pfizer was heavily invested in immuno-oncology combinations five years ago, but following setbacks, the pipeline has shifted considerably, shaped partly by the acquisition of Array.

Bavencio’s Survival Benefit Confirmed In Front-Line Maintenance Therapy For Advanced Urothelial Cancer

Further details of Merck KGaA/Pfizer-funded JAVELIN Bladder 100 study presented at this year’s ASCO confirm avelumab’s survival benefit when used as front-line maintenance therapy in patients with advanced urothelial cancer that has not progressed following initial chemotherapy.

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