Karyopharm up on uncertainty with advisory committee nod for Glaxo drug

Karyopharm Therapeutics (KPTI +5.2%) perks up, albeit on below-average volume, in apparent response to the release of a briefing document for Tuesday’s FDA advisory committee meeting on GlaxoSmithKline’s (GSK -1.0%) marketing application seeking accelerated approval of antibody-drug conjugate (ADC) belantamab mafodotin for the treatment of multiple myeloma (MM) patients who have received at least four prior lines of therapy.

The review team appears concerned with the ADC’s safety profile, specifically ocular toxicity, and is unconvinced that the company’s proposed actions to mitigate the risk will be adequate.

Karyopharm’s Xpovio (selinexor) is the only FDA-approved drug for “last-line” treatment of patients with relapsed/refractory MM, receiving the regulatory nod a year ago.

https://seekingalpha.com/news/3590262-karyopharm-up-5-on-uncertainty-advisory-committee-nod-for-glaxo-drug