Roche Holding AG RHHBY announced that the FDA has accepted the supplemental biologics license application (sBLA) seeking approval for its blockbuster PD-L1 inhibitor, Tecentriq as a chemotherapy free option to treat newly diagnosed patients with certain types of advanced non-small cell lung cancer (NSCLC).
The sBLA is looking to get Tecentriq approved, as a monotherapy, for first-line treatment of PD-L1-selected patients with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations.
With the FDA granting priority review to the sBLA, a decision is expected on Jun 19. The sBLA is based on data from the phase III IMpower110 study. Data from the study showed that Tecentriq alone demonstrated a significant improvement in overall survival compared with chemotherapy in the above patient population.
Roche’s stock has rallied 29.2% in the past year, outperforming the industry’s rise of 9.3%.
Tecentriq is presently approved for several cancer indications either as a monotherapy or in combination with other drugs. Its approved indications include NSCLC, small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.
Roche is working to expand the drug’s label further. The company currently has several phase III studies evaluating Tecentriq in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers, either alone or in combination with other drugs.
Tecentriq sales came in at CHF 1.9 billion in 2019, up 143%. If approved for further indications and in earlier-line settings for approved indications, sales can be higher in the future quarters.
However, competition is stiff in the first-line NSCLC market. Merck’s MRK PD-L1 inhibitor, Keytruda commands a strong place in first-line NSCLC market. Bristol-Myers Squibb Company’s BMY PD-L1 inhibitor, Opdivo is also in the race for first-line NSCLC treatment. Its regulatory application seeking approval of Opdivo plus Yervoy for the treatment of first-line NSCLC is under priority review. Other PD-L1 inhibitors available in the market are AstraZeneca’s AZN Imfinzi and Pfizer’s Bavencio.
Roche currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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