GlaxoSmithKline plc GSK announced that the European Commission has granted a conditional marketing authorization to its antibody drug conjugate Blenrep (belantamab mafodotin). The drug is now approved as a monotherapy for the treatment of multiple myeloma in adult patients who already received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and an anti-CD38 monoclonal antibody, having experienced disease progression on the last therapy.
Following the nod, Blenrep became the first anti-BCMA treatment available for the given patient population in Europe.
The approval was based on data from the pivotal DREAMM-2 study including 13-month follow-up data, which evaluated Blenrep in patients with heavily pre-treated multiple myeloma. Detailed results from the above-mentioned study showed that treatment with Blenrep monotherapy led to a clinically meaningful 32% overall response rate (ORR) under the 2.5 mg/kg regimen in the given patient population. The median duration of response was 11 months and the median overall survival was 13.7 months.
Earlier this month, the FDA granted an approval to Blenrep for the treatment of relapsed/refractory multiple myeloma in patients who were previously treated with an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Per the company, around 48,000 new cases of multiple myeloma are diagnosed each year across Europe. This represents a significant market opportunity for Blenrep, which could boost its sales and drive growth for Glaxo.
So far this year, Glaxo’s shares have declined 14.4% against the industry’s increase of 2%.
Notably, Glaxo has made significant progress in its oncology pipeline and doubled its assets in development off late. This has been achieved through the advancement of internal programs as well as a targeted business development including the January 2019 acquisition of Tesaro and the global alliance with Merck KGaA in the following month of February (to co-develop bintrafusp alpha/M7824, a promising new oncology medicine).
Glaxo now has a number of molecules with diverse mechanisms of action, providing an opportunity for many innovative cancer combinations. Meanwhile, the company divested its non-core Consumer Healthcare (CHC) nutrition business to Unilever UL and formed a Consumer HealthCare joint venture with Pfizer PFE to focus on its pharmaceuticals business, particularly oncology.
Zacks Rank & Key Pick
Glaxo currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Roche Holding AG RHHBY, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Roche’s earnings estimates have moved 2.7% and 3.6% north for 2020 and 2021, respectively, over the past 60 days. The stock has rallied 9.2% year to date.
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