Early Tecentriq OK Gives Roche/Genentech Jump On PD-L1 Bladder Cancer Market
By granting an approval four months ahead of schedule of Roche AG's and Genentech Inc.'s anti-PD-LI cancer immunotherapy Tecentriq (atezolizumab), the FDA may have helped the companies secure a better lead in the bladder cancer marketplace than the firms otherwise would have held. But already established immunotherapies, Merck & Co. Inc.'s Keytruda (pembrolizumab) and Bristol-Myer Squibb Co.'s Opdivo (nivolumab), are in hot pursuit.
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Roche's PD-L1 inhibitor Tecentriq in combination with chemotherapy improved progression-free survival in first-line bladder cancer, after the immunotherapy failed a confirmatory trial as monotherapy.
The PD-L1 inhibitor is the first checkpoint immunotherapy to gain approval in the tough-to-treat disease setting.
The number of novel drugs approved by FDA in 2016 was down versus prior years, and many of the drugs that did launch are off to a slow start. The expectation is increasingly for drugs to build sales over time.