Pfizer lung cancer drug misses key survival goal in Phase 3 trial
The company said the safety profile remained consistent with earlier studies and was considered manageable
The company said the safety profile remained consistent with earlier studies and was considered manageable
An exploratory overall survival signal also leaned in favor of the combination, though the companies noted the result remains preliminary
The safety profile was described as manageable, though not without notable toxicities
The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
Highlighting KEYTRUDA & expanding cancer pipeline
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev
A decision is expected by August 17, 2026 under the Prescription Drug User Fee Act timeline
Its a major breakthrough for women’s ovarian cancer care in Europe
The FDA approval makes PD-L1 IHC 22C3 pharmDx the only companion diagnostic approved to detect tumors expressing PD-L1 in esophageal or GEJ carcinoma patients for KEYTRUDA treatmen
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