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Array's NDAs for Melanoma Combo Accepted for Review by FDA

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Array BioPharma (ARRY - Free Report) announced that the FDA has accepted for review its two New Drug Applications (NDAs), seeking approval for the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) to treat patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA has set an action date of June 30, 2018 for both applications.

The NDA submissions were supported by an encouraging data from phase III COLUMBUS study (n=1577), conducted in two parts.

Array’s shares have underperformed the industry year to date. The stock has been up 14.9% compared with the industry’s gain of 16.5% in the same time frame.

In September 2016, Array had announced a positive top-line data from part 1 of the phase III study. The results from this evaluation showed that the combination (COMBO450) of (45 mg twice daily) and encorafenib (450 mg once daily) have significantly improved the progression-free survival (PFS) in comparison to Roche Holding AG’s (RHHBY - Free Report) Zelboraf (vemurafenib), thus meeting the primary endpoint. Additionally, the combo therapy was generally well-tolerated and all adverse events were consistent with previous trials.

In May 2017, the company had further revealed a positive data from part 2 of the COLUMBUS study, which was specifically designed to evaluate the given combination (COMBO300) by reducing encorafenib’s dose to 300mg compared with its lower dosage.

In fact, the median PFS for patients treated with COMBO300 was 12.9 months compared with the 9.2 months for patients treated with single agent encorafenib. This fusion was also endured well during the study.
Currently, Array is evaluating encorafenib, in collaboration with Eli Lilly and Company’s (LLY - Free Report) Erbitux (cetuximab) with or without binimetinib, in the phase III BEACON CRC study in patients with BRAF V600E-mutant colorectal cancer. This experimental trial is being performed under a Special Protocol Assessment (“SPA”) with the FDA. Patient enrollment for the same is expected to be complete in 2018.

We remind investors that Array had regained development and commercialization rights for binimetinib from Novartis Pharma AG (NVS - Free Report) in March 2015.

Array BioPharma Inc. Price

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Array 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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