GlaxoSmithKline Gets FDA Approval For Blood Cancer Drug

GlaxoSmithKline plc GSK announced Wednesday the United States Food and Drug Administration had approved its cancer drug aimed at treating refractory multiple myeloma in adults.

What Happened

The monotherapy, belantamab mafodotin, or BLENREP, stands approved for those patients who have received four prior therapies including treatment with an immunomodulatory agent, GSK said in a statement. 

The drugmaker has secured five major medical approvals in 2020 and the latest drug is the second oncology approval for the company in four months.

Multiple Myeloma is the second most common form of blood cancer in the U.S. and is “an incurable and devastating disease,” according to GSK Chief Scientific Officer Hal Barron.

Why It Matters

BLENREP will be competing with Johnson & Johnson JNJ and Genmab A/S's GNMSF Darzalex, and is considered to be an important part of GSK’s oncology efforts, Reuters noted earlier.

The European Medicines Agency also reportedly recommended an approval for the drug last month. 

GSK and its partner Sanofi SA SNY reached an agreement with the United Kingdom government to supply 60 million doses of its COVID-19 vaccine last week. A regulatory approval for the vaccine candidate is expected in the first half of 2021, if data from clinical trial is positive.

Price Action 

GSK shares traded 0.17% lower at $41.14 in the after-hours session Wednesday.

Photo courtesy: GlaxoSmithKline plc