Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later failed confirmatory studies.
The drugmaker said Monday that the FDA had approved Imfinzi, its PD-L1 inhibitor, for first-line extensive-stage small cell lung cancer, with platinum chemotherapy. The drug creates a new competitive threat to Roche's Tecentriq, which is approved for the same disease setting.
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The FDA gave priority review to the British drugmaker's application for Imfinzi in first-line extensive-stage SCLC. Data published last month showed a statistically significant improvement in overall survival for the drug plus chemotherapy compared with chemotherapy alone.
The company said the Phase III CASPIAN study of Imfinzi in first-line, extensive-stage small-cell lung cancer was successful, but did not disclose further details. Roche's Tecentriq is already approved for that indication, which accounts for two-thirds of SCLC cases.
The KEYNOTE-119 study failed to show a survival benefit in TNBC patients. The news comes two months after the FDA gave accelerated approval to a rival, Roche's Tecentriq.
The PD-L1 inhibitor is the first new drug for ES-SCLC in more than 20 years. Meanwhile, Merck is also running a Phase III study of its PD-1 inhibitor in first-line ES-SCLC.
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The news closely followed that of the FDA approving the first immunotherapy drug for cancer, Roche's Tecentriq, in combination with Abraxane.
The drug received accelerated approval for combination with Celgene's Abraxane based on Phase III data. According to a study, PD-L1-positive patients account for 26 percent of TNBC patients overall.
Two drugs - Pfizer and Merck KGaA's Bavencio and AstraZeneca's Imfinzi - saw Phase III trials fail, while anticipated negative results prompted Roche to withdraw Tecentriq from regulatory review.
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Roche’s anti-PD-L1 drug Tecentriq took a step closer to regulatory approval as a combination drug for untreated non-small cell lung cancer patients. So why weren’t investors impressed?