Pfizer Inc. PFE announced that the FDA granted Breakthrough Therapy designation to its lung cancer drug, Xalkori (crizotinib) for two new indications.
Xalkori is already marketed for the treatment of ALK+ or ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). In-fact, it is only FDA-approved treatment indicated for both ALK-positive and ROS1-positive metastatic NSCLC.
The FDA granted Breakthrough Therapy designation to Xalkori for the treatment of patients with metastatic NSCLC with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The designation for this indication was supported by results from an expansion cohort of the phase I PROFILE 1001 study, in which Xalkori showed antitumor activity.
Another indication for which Breakthrough Therapy designation was granted to Xalkori was for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is ALKpositive. The designation for this indication was supported by two studies — Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). The studies showed compelling antitumor activity in pediatric and adult patients treated with Xalkori.
The designation from the FDA is intended to expedite the development and review of drugs with early evidence of substantial potential clinical benefit to patients.
Shares of Pfizer have declined 1.5% year to date, compared with the industry’s decline of 6%.
NSCLC is a difficult-to-treat disease, accounting for about 85% of lung cancer cases. At present, the lung cancer treatment market is highly crowded with drugs like Bristol-Myers Squibb’s BMY Opdivo, Merck’s MRK Keytruda, Roche’s RHHBY Alecensa, Novartis’ Zykadia and Taxotere among others.
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Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.
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