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Pfizer's Braftovi sNDA Accepted by FDA for Priority Review

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Pfizer, Inc. (PFE - Free Report) announced that the FDA has accepted the supplemental new drug application (sNDA) looking for label expansion of its cancer drug, Braftovi (encorafenib). The sNDA seeks approval for Braftovi in combinaition with Eli Lilly’s (LLY - Free Report) EGFR antagonist, Erbitux (cetuximab), for treating BRAFV600E-mutant metastatic colorectal cancer (mCRC) after one or two prior therapy. The FDA has also granted priority review to the sNDA and a decision from the regulatory authority is expected by April 2020.

We note that Pfizer added Braftovi to its portfolio with the acquisition of Array BioPharma earlier this year for $11.4 billion. Braftovi is approved in combination with Mektovi (binimetinib) for the treatment of BRAF-mutant melanoma, the deadliest form of skin cancer.

A similar label expansion application for Braftovi in under review in Europe. The application was filed by Array BioPharma’s European partner, Pierre Fabre.

Shares of Pfizer have decreased 10.9% so far this year against the industry’s increase of 10.2%.

The sNDA was based on data from phase III BEACON CRC study, which evaluated Braftovi in combination with Erbitux (Braftovi doublet), and a combination of Braftovi, Erbitux and Mektovi (Braftovi triplet) compared to Erbitux plus irinotecan-containing regimens in previously treated patients with advanced BRAFV600E-mutant mCRC.

Data from the study showed that patients treated with Braftovi doublet demonstrated a statistically significant improvement in objective response rate and overall survival compared to the control arm. Patients treated with Braftovi triplet showed comparable efficacy compared to Braftovi doublet.

Currently, there are no FDA-approved treatments available for the given patient population. The data from the BEACON CRC study clearly showed a significant improvement in patients compared with the available standard-of-care options for this patient population. This is likely to boost sales of the drug upon potential approval.

Meanwhile, a phase II study — ANCHOR — is evaluating the combination of Braftovi doublet and triplet regimens in first-line mCRC with similar mutation. The study is expected to be completed in late 2020.

Pfizer has strengthened its cancer portfolio in 2019 through acquisitions, new drug approval and label expansions. Earlier this month, sNDA seeking label expansion of Xtandi in men with metastatic castration-sensitive prostate cancer was approved in the United States. Sales from the company’s oncology drugs grew more than 19% year over year in the first nine months of 2019 to $6.5 billion. Meanwhile, Pfizer is also restructuring its units to form a new company with a diversified portfolio of innovative drugs and vaccines. The company has merged its Consumer Healthcare (“CHC”) business with GlaxoSmithKline's (GSK - Free Report) CHC business by forming a joint venture. Pfizer holds a 32% stake in the JV.  Meanwhile, merger of its Upjohn unit with Mylan (MYL - Free Report) is pending. These initiatives are likely to boost growth for the company going forward.

Zacks Rank

Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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