Roche Holding AG RHHBY announced that the FDA has approved its lung cancer drug, Alecensa, for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer Inc.’s PFE Xalkori (crizotinib).
Alecensa gained an accelerated approval from the FDA based on its tumor response rate and duration of response. Data from the pivotal studies suggested that Alecensa was able to shrink tumors in up to 44% of patients with ALK-positive NSCLC who had progressed on Xalkori.
In addition, Alecensa was able to shrink central nervous system (CNS) tumors in about 60% of patients.
We note that Alecensa is also being evaluated in comparison to Xalkori in a phase III study as a first-line treatment for patients with advanced ALK-positive NSCLC.
The lung cancer treatment market is highly crowded with drugs like Opdivo, Keytruda and Zykadia among others.
Meanwhile, the company continues to progress on its cancer treatment portfolio. Last month, the company’s skin cancer drug, Cotellic, was approved in both the U.S. and the EU for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf (vemurafenib).
Roche currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN and Corcept Therapeutics Incorporated CORT, both sporting a Zacks Rank #1 (Strong Buy).
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