GSK wins FDA approval of Blenrep for multiple myeloma

[GlaxoSmithKline Headquarters In Brentford, London]
Leon Neal/Getty Images News

* The US FDA has granted approval of GSK's (NYSE:GSK [https://seekingalpha.com/symbol/GSK]) Blenrep (belantamab mafodotin) in combination with Johnson & Johnson's (JNJ [https://seekingalpha.com/symbol/JNJ]) Velcade (bortezomib) and dexamethasone as a second-line therapy for multiple myeloma.
* The approval marks the return of Blenrep to the US market after it was ordered removed [https://seekingalpha.com/news/3910354-gsk-to-stop-selling-blood-cancer-therapy-blenrep-in-us] from the market in 2022 following the failure of a confirmatory trial. It received accelerated approval in 2020.
* In July, an FDA advisory committee voted [https://seekingalpha.com/news/4468548-gsk-stock-falls-fda-advisors-vote-against-blenrep] 5-3 against the benefit-risk profile of Blenrep in combination with Velcade and dexamethasone.
* Approval [https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belantamab-mafodotin-blmf-relapsed-or-refractory-multiple-myeloma] was based on results from the phase 3, open-label DREAMM-7 study in patients who had failed on at least one prior therapy.
* Blenrep's label includes a Boxed Warning on the risk of ocular (eye) toxicity.
* Despite the approval, GSK shares are down ~6% in after-hours trading Thursday.

MORE ON GSK

* GSK: Compelling Value, No Red Flags Ahead Of Earnings, Blenrep FDA Decision Soon [https://seekingalpha.com/article/4829174-gsk-compelling-value-no-red-flags-ahead-of-earnings-blenrep-fda-decision-soon]
* GSK's Hidden Growth Engines Beyond HIV And Oncology [https://seekingalpha.com/article/4828903-gsk-hidden-growth-engines-beyond-hiv-oncology]
* GSK: Walmsley Out, Miels In - I'm Watching The CEO Transition From The Sidelines [https://seekingalpha.com/article/4826693-gsk-walmsley-out-miels-in-im-watching-the-ceo-transition-from-the-sidelines]
* Alector slumps on late-stage trial setback for GSK-partnered dementia candidate [https://seekingalpha.com/news/4506546-alector-posts-trial-setback-gsk-partnered-drug]
* Astra, GSK up after report on U.K. – U.S. drug pricing deal [https://seekingalpha.com/news/4505307-astra-gsk-up-uk-us-drug-pricing-deal]