Summary
- The FDA accepted the BLA for liso-cel to treat patients with relapsed/refractory diffuse large B-cell lymphoma.
- A PDUFA date for liso-cel for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma has been set for Aug. 17, 2020.
- The completed acquisition of Celgene brought on board several new oncology products like Revlimid, Pomalyst and Abraxane.
- Bristol-Myers Squibb will have an issue with patents for Revlimid a few years from now, because one company will have a limited launch for its generic Revlimid drug in March of 2022.
- I do much more than just articles at Biotech Analysis Central: Members get access to model portfolios, regular updates, a chat room, and more. Get started today ยป
Bristol-Myers Squibb (BMY) announced that the FDA accepted its Biologics Licensing Application (BLA) for liso-cel for the treatment of adult patients with relapsed/refractory large B-cell lymphoma. Analysts estimate that liso-cel could reach billions in peak sales, which will definitely help the company with its revenue. More important than that, patients will have a better treatment option for their cancer. The FDA wouldn't have given liso-cell Priority Review if it didn't meet several specified criteria. Part of the criteria is that a treatment must be shown to be safer or effective over currently available therapies. Such a review also will cut down on the amount of time that the FDA will decide upon approval of the treatment itself.
CD19 The Target Of Choice For Diffuse Large B-Cell Lymphoma
The FDA has set up a PDUFA date of Aug. 17, 2020, for liso-cel (lisocabtagene maraleucel) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma after at least two prior therapies. This type of patient population is not easy to treat because they already have gone through prior therapies. However, liso-cel is the perfect target for this patient population because it's a anti-CD19 CAR-T. What makes the anti-CD19 CAR-T liso-cel product so good is that CD19 is found in all B lineage cells, while at the same time not found on plasma cells. Anti-CD19 CAR-T therapies have become ideal for hematological malignancies because of this. This is especially true in relapsed/refractory patient populations. This is evidenced by the positive clinical data that was generated from the TRANSCEND NHL 001 study. This study recruited a total of 268 patients with relapsed/refractory large B-cell lymphoma. These include:
- Diffuse large B-cell lymphoma (DLBCL)
- High grade lymphoma
- Primary mediastinal B-cell lymphoma
- Grade 3B follicular lymphoma
This study ended up evaluating a total of 256 patients. The overall response rate (ORR) for patients treated with liso-cel was 73%. Of these patients who achieved an ORR, 53% had a complete response (NYSE:CR) to treatment. The median duration of response ((mDOR)) was not reached after a follow up of 12 months. Additional data included:
