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Pfizer gets Array deal payoff as FDA approves Braftovi

Drug is second-line treatment for colorectal cancer

Pfizer HQ

Pfizer’s run of approvals for new targeted cancer drugs has continued with an FDA approval for Braftovi alongside Eli Lilly’s Erbitux as a second-line treatment for colorectal cancer (CRC).

The US regulator gave the go-ahead for the two drugs as a treatment for adults with BRAF V600E mutation-positive CRC whose cancer has progressed despite first-line therapy, and according to Pfizer the combination is “the first and only FDA-approved targeted regimen” for these patients.

Pfizer acquired BRAF inhibitor Braftovi (encorafenib) as part of its $11.4bn takeover of Array BioPharma last year, which was driven largely by the potential of the drug in CRC.

Braftovi is already approved alongside Array’s other product – MEK inhibitor Mektovi (binimetinib) – for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, but CRC is considered to be a much larger opportunity.

EvaluatePharma has estimated that Array’s drugs will make $1.2bn in revenue by 2024, with around two-thirds of that total ($700m) coming from the CRC indication.

The FDA approval is based on the results of the phase 3 BEACON CRC trial, which tested Braftovi plus Erbitux as a doublet therapy as well as the triplet of Braftovi, Erbitux and Mektovi.

The FDA granted a priority review to the doublet regimen only, after updated results from the trial showed that the triplet wasn’t able to provide any additional improvement in overall survival compared to Braftovi and Erbitux alone.

An earlier analysis showed a slight edge for the three-drug combination, but once it was clear that the survival curves in the trial were converging, the decision was taken not to file the triplet with the FDA.

In the trial, Braftovi and Erbitux showed a median overall survival of 8.4 months, compared with 5.4 months for Erbitux plus chemotherapy, while the overall response rates for the two arms were 20% and 2%, respectively.

“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” said Scott Kopetz of the University of Texas MD Anderson Cancer Center, a lead investigator in the study.

Braftovi and Erbitux is “a much-needed new treatment option for these patients”, he added.

The new Braftovi indication extends a long run of targeted cancer drug approvals for Pfizer, dating back to 2018.

Since then it has claimed FDA approvals for Lorbrena (lorlatinib) in second-line ALK-positive NSCLC, SMO inhibitor Daurismo (glasdegib) for acute myeloid leukaemia, PARP inhibitor Talzenna (talazoparib) for advanced breast cancer, and Vizimpro (dacomitinib), a drug that could challenge AstraZeneca’s fast-growing Tagrisso (osimertinib) in lung cancer.

Article by
Phil Taylor

9th April 2020

From: Research

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