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Pfizer's Braftovi Combo Gets FDA Nod for Colorectal Cancer

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Pfizer Inc. (PFE - Free Report) announced that the FDA has approved its cancer drug Braftovi (encorafenib) in combination with Eli Lilly’s (LLY - Free Report) EGFR antagonist, Erbitux (cetuximab), for the treatment of BRAFV600E-mutant metastatic colorectal cancer in patients having received prior therapy.

Following this nod, the Braftovi combo became the first and the only FDA-approved targeted regimen for the said indication. The FDA approval was based on data from the phase III BEACON CRC study, the only analysis specifically designed to evaluate the given patient population.

Data from the study showed that Braftovi plus Erbitux demonstrated a median overall survival (OS) of 8.4 months compared to 5.4 months for the control arm (irinotecan with Erbitux or Folfiri with Erbitux).

Moreover, the Braftovi combo showed an objective response rate (ORR) of 20% versus 2% for control arm while the median progression-free survival was 4.2 months in the Braftovi combo arm compared to 1.5 months in the control arm.

Notably, in December 2019, the FDA accepted and granted a priority review to the supplemental new drug application (sNDA) for Braftovi plus Erbitux to address the above indication

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

Shares of Pfizer have lost 11.7% so far this year compared with the industry’s decrease of 9.7%.

We remind investors that Pfizer added Braftovi to its portfolio with the acquisition of Array BioPharma in 2019. Braftovi is approved in combination with Mektovi (an oral small molecule MEK inhibitor) for the treatment of BRAF-mutant melanoma, the deadliest form of skin cancer.

Braftovi recorded sales worth $48 million in 2019. The label expansion of the drug, is likely to boost its sales in 2020.

Zacks Rank & Other Stocks to Consider

Pfizer currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the large cap pharma sector include AbbVie Inc. (ABBV - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) , both holding the same Zacks Rank as Pfizer. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AbbVie’s earnings estimates have moved 1.4% north for 2020 and 0.6% north for 2021 over the past 60 days.

Bristol-Myers’ earnings estimates have been revised 6.2% upward for 2020 and 0.5% upward for 2021 over the past 60 days.

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