Sunday, July 4, 2021

J&J, Legend Biotech’s multiple myeloma CAR-T scores FDA priority review, setting up a clash with BMS’ Abecma

When Bristol Myers Squibb and bluebird bio scored an FDA nod for their multiple myeloma CAR-T drug Abecma in March, industry watchers knew a competitor from Johnson & Johnson and Legend Biotech wasn’t too far behind. Now, that rival is in the FDA’s fast lane.

J&J and Legend’s ciltacabtagene autoleucel, otherwise known as cilta-cel, scored an FDA priority review, setting up an FDA decision by Nov. 29. The candidate, a BCMA-directed CAR-T therapy, is up for approval in patients with relapsed or refractory multiple myeloma.  

If approved, the drug would challenge BMS and bluebird bio’s new CAR-T Abecma, which won its March green light after a previous rejection.

The FDA’s labeling decision will be a key point to watch if J&J’s med scores an approval. Abecma carries an FDA approval in patients who have tried and failed on at least four prior therapies, so if J&J’s medicine gets into an earlier line of use, that’d be an immediate advantage.

RELATED: Bristol Myers, bluebird bio have their BCMA CAR-T nod, but latecomer J&J could have an advantage: analysts 

And they have study data that could make that happen. J&J and Legend based their FDA application on an open-label phase 1b/2 study in adults with relapsed and/or refractory multiple myeloma who had tried three previous therapies. After one year, 97% of patients responded, and 67% showed no signs of cancer.

Those data attracted attention from leading multiple myeloma experts. After speaking with a specialist at a “leading academic center,” RBC Capital Markets analysts wrote to clients in March that the doctor was impressed by the “deep and durable” responses.

J&J’s drug is also associated with higher toxicity, the expert noted, so she envisioned using it in fitter patients to start. The CAR-T drugs weren’t studied head-to-head. 

RELATED: Bristol’s new myeloma CAR-T needs a hefty discount to be cost-effective, watchdogs say while endorsing GSK’s Blenrep 

While pricing is still up in the air for the J&J and Legend Biotech med, the Institute for Clinical and Economic Review has already suggested a price of $317,000 to $475,000 based on the available data. BMS’ med costs $419,500 per dose before any discounts.

Another new multiple myeloma drug, GlaxoSmithKline’s Blenrep, costs $8,277 per vial before discounts and is given every three weeks.

Source link

Stay Connected


Latest Articles

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...

Telangana caps Covid treatment charges in private hospitals

Hyderabad: The government of Telangana on Wednesday issued orders fixing treatment and investigation charges for Covid-19 in private hospitals.The state government, which had capped...