It’s been a long road for Pfizer’s dacomitinib, but the targeted lung cancer drug final has an FDA green light.
Late Thursday, the agency handed Pfizer an OK for the cancer-fighter, which will bear the trade name Vizimpro. The approval clears the med, which will launch with a list price of $12,400 per month, to treat metastatic non-small cell lung cancer patients with one of two specific EGFR mutations.
The go-ahead comes more than a year after Pfizer trotted out positive phase 3 results for the drug at 2017’s American Society of Clinical Oncology (ASCO) annual meeting. Data showed that Vizimpro had beaten out an in-class rival, AstraZeneca’s Iressa, at delaying cancer growth in newly diagnosed patients, paring down the risk of progression or death by 41%.
At that point, late-stage trial wins were new for Vizimpro, which failed a pair of studies pitting it against Roche’s Tarceva back in 2014 before Pfizer went back to the drawing board.
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“Our understanding of EGFR TKIs has evolved, and we now know that these agents are most effective in patients with EGFR-activating mutations,” a company spokeswoman said by email last June. The study “specifically studied use of dacomitinib in subpopulations … of the EGFR mutation,” which were “selected based on the outcomes from several previous clinical trials,” she added.
Now, Pfizer has therapies that target three different lung cancer biomarkers, Andy Schmeltz, global president of Pfizer oncology, pointed out in a statement. Vizimpro will join Xalkori, approved for ALK-positive and ROS1-positive NSCLC, in Pfizer’s targeted lung cancer lineup.
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Like Xalkori, though—which is up against ALK rivals Zykadia from Novartis and Alecensa from Roche, and could soon see Takeda’s Alunbrig in the mix—Vizimpro has plenty of marketplace competition. In addition to Iressa, it’ll square off against Tarceva—which has already topped it in trials—and Boehringer Ingelheim’s Gilotrif.