J&J secures EMA backing for earlier CAR-T use in multiple myeloma

Dive Brief:

• The European Medicine Agency’s main drug review committee on Friday supported expanding the approval of Johnson & Johnson and Legend Biotech’s cell therapy Carvykti for earlier treatment of multiple myeloma. 
• The Committee for Medicinal Products for Human Use recommended Carvykti be used in people with relapsed and refractory multiple myeloma who have received at least one previous therapy. Currently, the CAR-T therapy is cleared following at least three prior treatments. 
• The EMA’s recommendation now goes to the European Commission for marketing authorization, which typically follows within 60 days. Bristol Myers Squibb’s competing CAR-T therapy Abecma also recently received EMA backing for earlier multiple myeloma use.

Dive Insight:

Carvykti and Abecma have proved effective in earlier treatment of multiple myeloma, before patients cycle through other drugs currently used to hold their blood cancer in check. As with other CAR-T therapies for leukemia and lymphoma, their makers are using that evidence to try to broaden use.  

With their recommendations for first Abecma and now Carvykti, European regulators have moved ahead of the Food and Drug Administration, which delayed a decision on Abecma and next month will convene a panel of expert advisers. The panel is set to discuss overall survival data for both therapies, scrutiny that comes as the FDA has warned of secondary cancers following CAR-T treatment. 

The advisers are set to meet March 15, with decisions from the FDA likely to follow afterward. 

In Europe, both therapies are now in position to receive authorization for early treatment. Their labels could look different, however. 

EMA regulators last month recommended Abecma for people who have received at least two prior therapies, and have demonstrated disease progression on the last treatment. 

With Carvykti, by contrast, the EMA is recommending use in people who are refractory to the drug Revlimid and have received at least one previous treatment.

This difference in labeling could be a “significant advantage” for Carvykti, wrote Jefferies analyst Kelly Shi in a Friday note to clients.

Both Carvykti and Abecma are designed to target a protein known as BCMA that’s found on malignant cells. The therapies are personalized, built from a patient’s immune cells and then engineered to home in on BCMA. 

J&J, which licensed Carvykti from Legend Biotech, recorded $500 million in global sales last year, compared to the $358 million Bristol Myers earned from Abecma.

Both companies have been hard pressed to manufacture their therapies, which require an intensive production process, fast enough to meet demand.

Also on Friday, the EMA recommended expanded clearances for five other medicines, as well as initial approval for Biogen’s ALS medicine Qalsody and several other therapies. 

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