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The Readout Damian Garde & Meghana Keshavan

FDA approves first cell therapy for multiple myeloma

The Food and Drug Administration late Friday night gave the green light to a fifth CAR-T medicine — but this one is the first personalized cell therapy approved to treat multiple myeloma. It's also the first approved to target the BCMA protein.

Abecma, made by Bristol Myers Squibb and Bluebird Bio, will cost $419,500, and is only meant to be used in patients who have failed four or more previous lines of therapy. 

“This is a new chapter and a new opportunity for patients and caregivers in myeloma,” one multiple myeloma expert told STAT’s Adam Feuerstein. “We now have a new modality, if you want to call it that, for myeloma therapy, so it’s very exciting and likely the first of many such approvals.” 

Read more.

Answering your questions on the future for cancer immunotherapy

Are there any convincing data that natural killer cells can actually be engineered to target solid tumors? How about mRNA vaccines: Would they need to be used in tandem with a checkpoint inhibitor to prove most effective? And could TIGIT-based combination treatments work where existing immunotherapies have been unable? 

Last week, STAT’s Adam Feuerstein hosted a webinar projecting what cancer immunotherapy will look like in the coming years — and now he's taking on some of the biggest questions from those who attended. 

Read more. 

Vir, GSK antibody want an EUA from FDA

Vir Biotechnology and GlaxoSmithKline have co-developed an antibody drug aimed at mitigating the severity of Covid-19 — and have now appealed to the FDA for emergency use authorization of the therapy. The EUA submission is based on interim Phase 3 data that showed the drug reduced hospitalization or death by 85% compared to placebo. 

Vir and GSK’s antibody is lagging behind similar therapies from Eli Lilly and Regeneron — but those drugs haven’t been heavily utilized because they have to be given intravenously very soon after patients begin showing symptoms. Vir and GSK, on the other hand, have also been developing an intramuscular injection that will be tested soon in Phase 3 trials. This, FierceBiotech points out, could have a larger impact on the longer-term Covid-19 response.

Let's talk about gene therapy

Gene therapy has had its share of ups and downs in recent months. There was the cancer scare at Bluebird Bio. And Novartis last week announced it’d shut down its Colorado gene therapy plant, having possibly overestimated its commercial prospects. But there’s the aforementioned CAR-T therapy for multiple myeloma — and several more gene therapies still in the pipeline. 

What will gene therapy look like in the future? STAT’s Damian Garde is hosting a conversation tomorrow with Katherine High of AskBio, a gene therapy player.

You can sign up here.

More reads

  • Covid-19 vaccines have alerted the world to the power of RNA therapies. (Economist)
  • Amazon, on the move in health care, is granted authorization for its own Covid-19 test. (STAT)
  • Novartis pushes back on chairman's 'inaccurate and inconsistent' comments undermining bribery settlement. (Endpoints)

Thanks for reading! More tomorrow,

Damian

Monday, March 29, 2021

STAT

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