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AstraZeneca's (AZN) Imfinzi Gets FDA Priority Tag for SCLC

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AstraZeneca plc’s AZN regulatory application looking for label expansion of its PD-L1 inhibitor Imfinzi was accepted and granted priority by the FDA. The supplemental biologics license application (sBLA) sought approval of Imfinzi for the first-line treatment of extensive-stage small cell lung cancer (SCLC) — the most aggressive type of lung cancer. With the FDA granting priority review designation, a decision is expected in the first quarter of 2020.

The sBLA was based on positive results from the phase III CASPIAN study. Data from the study, presented previously, showed that treatment with Imfinzi plus platinum-based chemotherapy led to a statistically-significant and clinically-meaningful improvement in overall survival (OS) versus chemotherapy alone. The median OS was 13.0 months in the Imfinzi plus chemotherapy arm versus 10.3 months for standard-of-care medicines, which means the risk of death was reduced by 27% on treatment with Imfinzi plus chemotherapy

Shares of AstraZeneca have rallied 27.6% this year so far compared with the industry’s increase of 6.4%.



Imfinzi Is presently marketed as a monotherapy for patients with locally-advanced, unresectable (stage III) non-small cell lung cancer, whose disease has not progressed following platinum-based chemotherapy concurrent with radiation therapy. Other than this early-stage lung cancer indication, Imfinzi is also marketed for second-line advanced bladder cancer. Imfinzi is also being evaluated for multiple other cancers (either alone or in combination with other regimens) and has bright long-term prospects.

Imfinzi recorded sales of $1.05 billion in the first nine months of 2019, mainly driven by strong demand in lung cancer patients. If Imfinzi is approved for SCLC, it can cater to a broader lung cancer patient population, which can bring in additional sales. It also improves the drug’s competitive position against other PD-1 and PD-L1 inhibitors.

Other PD-L1 inhibitors on the market are Merck’s (MRK - Free Report) Keytruda, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio. While Opdivo and Keytruda are approved to treat SCLC in third- or later-line setting, Tecentriq in combination with chemotherapy was approved this year for first-line extensive-stage SCLC indication.

AstraZeneca 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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