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Glaxo's Multiple Myeloma Candidate Gets FDA's Priority Review

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GlaxoSmithKline plc (GSK - Free Report) announced that the FDA has granted priority review to its biologics license application (BLA) for belantamab mafodotin. The company is seeking approval of the candidate for the treatment of relapsed/refractory multiple myeloma in patients who are previously treated with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The regulatory body generally grants a priority review to drugs that have the potential to treat a serious condition and if approved, would substantially improve safety or effectiveness.

The BLA was based on data from the pivotal DREAMM-2 study. Last month, Glaxo announced detailed results from the above-mentioned study, which evaluated two doses of belantamab mafodotin in patients with heavily pre-treated multiple myeloma. Per the company, treatment with belantamab mafodotin led to a clinically meaningful 31% overall response rate (ORR) under the 2.5 mg/kg regimen in such patients.

In August 2019, the study had met its primary endpoint by showing a clinically meaningful overall response rate with belantamab mafodotin in the above patients.

Per the company, belantamab mafodotin has potential to be the first anti-BCMA treatment available to the given patient population. The candidate is also being evaluated in several studies for other forms of multiple myeloma.

Shares of Glaxo have gained 21.6% in the past year compared with the industry’s rally of 15.1%.

Notably, Glaxo made a significant progress in its oncology pipeline of late and now boasts 16 assets in developmental stage. This is achieved through advancement of internal programs and targeted business development including the January 2019 acquisition of Tesaro and the February 2019 global alliance with Merck KGaA (to co-develop bintrafusp alpha/M7824, a promising new oncology medicine).

The company is developing dostarlimab for treating second-line endometrial cancer. The NDA filing for the candidate is expected soon.

Meanwhile, Glaxo now has a number of molecules with diverse mechanisms of action, providing an opportunity for many innovative cancer combinations. Last August, Glaxo and Pfizer PFE closed their previously announced merger of their respective consumer healthcare units into a new joint venture (JV) to focus on pharmaceuticals business, particularly oncology. Moreover, Zejula, the ovarian cancer drug added to Glaxo’s portfolio from the Tesaro buyout, was approved in October 2019 for addressing late-stage ovarian cancer.

Zacks Rank & Stocks to Consider

Glaxo currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the large cap pharma sector include Roche Holding AG RHHBY and Eli Lilly and Company LLY, both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche’s earnings estimates have moved 1.9% north for 2020 over the past 60 days. The stock has rallied 30.7% in the past year.

Eli Lilly’s earnings estimates have been revised 3.2% upward for 2020 over the past 60 days. The stock has jumped 18.6% in the past year.

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