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GSK secures US FDA priority review for key pipeline blood cancer therapy

GlaxoSmithKline PLC said its lead experimental treatment for multiple myeloma has been granted a priority review by the U.S. Food and Drug Administration, increasing the likelihood that it will be the first therapy of its kind on the market.

Known as belantamab mafodotin, or GSK2857916, the therapy received an expedited review based on data from the Dreamm-2 trial, where 31% of heavily pre-treated patients with multiple myeloma saw an improvement in their disease. The study was recently published in The Lancet Oncology.

Belantamab mafodotin is a treatment directed against the B cell maturation antigen, or BMCA, a protein found on the surfaces of plasma cells and overexpressed on malignant plasma cells. The anti-BCMA agent causes the death of tumor cells that overexpress BCMA and stops their rapid multiplication.

Belantamab mafodotin — granted a breakthrough-therapy designation by the FDA in 2017 for experimental drugs that address a significant unmet need — was developed from the ashes of GSK's cancer business, after the Brentford, U.K.-based pharmaceutical group agreed to an asset swap with Swiss peer Novartis AG in 2015. The deal saw GSK handing over much of its cancer portfolio and the related scientists, in return for Novartis' vaccines business and a consumer joint venture.

However, the U.K.-based drugmaker rebuilt its cancer franchise in the last year. The arrival of Hal Barron as head of research and development in 2018 heralded a renewed focus on cancer and the immune system — at the expense of GSK's older respiratory franchise.

In just over a year, GSK acquired Tesaro Inc., bringing in its first targeted therapy PARP-inhibitor with Zejula, as well as an established U.S.-based oncology sales force and the related infrastructure. The U.K. drugmaker also signed deals with companies, including Merck KGaA, to bolster its pipeline and now has 17 experimental assets in oncology.

GSK's head of oncology, Axel Hoos, has forecast that GSK2857916, the anti-BCMA agent, could attain annual sales of $5 billion — an estimate that is in line with those of HSBC analysts Steve McGarry and Julie Mead.

The HSBC analysts have a "buy" rating on GSK based on valuation and margin expansion resulting from the successful development of oncology assets, a move to a specialty drug model and a possible spin-off of the consumer business.

"In our view, BCMA, the target for [GSK2857916], could be the best target in multiple myeloma discovered to date given its early and durable expression, clinical data with anti-BCMA drug candidates seen thus far and the potential to increase the efficacy of anti-BCMA approaches with a gamma secretase inhibitor," the analysts said in a note to clients following the Dreamm-2 data on Dec. 18. "[GSK2857916] is a key pillar of our GSK margin transformation thesis."