Biotech and J&J Likely to Receive FDA Approvals for CAR-T Therapy

As per the trusted sources, at the times when Bristol Myers Squibb and bluebird bio got FDA approval in March for their multiple myeloma CAR-T drug Abecma, the industry people were aware that the competitor from Legend Biotech and J&J wasn’t too far behind. Now that company is in the fast lane of the FDA.

J&J and Legend’s launched ciltacabtagene autoleucel, also known as cilta-cel, was also approved by the FDA on November 29, the previous year. Further, another drug by them, which is BCMA-directed CAR-T therapy, is also waiting for heads up by the FDA with the refractory or relapsed multiple myeloma.

If this drug gets approval from the FDA, it will turn out to be a huge competition for the BMS and bluebird bio’s new CAR-T, Abecma, who won the approval in March the previous year, after witnessing a rejection before. It carries an approval among the patients who have been trying for a long time with four of their therapies so that if the J&J therapy gets approval just in its first attempt, it would be an advantage to the company.

Moreover, it is totally possible that the study data could make that happen, which just gained attention from the experts in the field of cancer. As per the reports, an expert on myeloma treatment who has tried all the three therapies in the past stated that he was impressed by the deep and durable treatment caused by the therapy. However, the J&J drug is more toxic, as stated by the experts, so they are testing it on fitter patients.