FDA roundup: Recent approvals, drugs in the pipeline for lymphoma treatment
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The treatment landscape of lymphoma has expanded rapidly within the last year, including recent FDA approvals and new designations of drugs in the pipeline.
Healio has compiled a list of recent FDA decisions to highlight current expanses in treatment options and new therapies on the horizon.
1. On Nov. 10, the FDA approved brentuximab vedotin (Adcetris, Seagen) in combination with chemotherapy for treatment of certain children with Hodgkin lymphomar. Read more.
2. On Oct. 27, the FDA granted fast track designation to MT-101 (Myeloid Therapeutics), an investigational chimeric antigen receptor monocyte, for the treatment of relapsed or refractory peripheral T-cell lymphoma. Read more.
3. On Sept. 28, the FDA granted regenerative medicine advanced therapy designation to CTX130 (CRISPR Therapeutics), a chimeric antigen receptor T-cell therapy under development for the treatment of mycosis fungoides and Sézary syndrome. Read more.
4. On Aug. 1, the FDA granted priority review to omidubicel (Gamida Cell), an investigational donor-based stem cell therapy for patients with hematologic malignancies undergoing allogeneic hematopoietic stem cell transplantation. Read more.
5. On July 14, the FDA approved crizotinib (Xalkori, Pfizer) for treatment of adults and children aged 1 year or older with anaplastic lymphoma kinase-positive unresectable, recurrent or refractory inflammatory myofibroblastic tumors. Read more.
6. On July 5, the FDA granted priority review to mosunetuzumab (Genentech) for treatment of certain patients with relapsed or refractory follicular lymphoma. Read more.
7. On June 24, the FDA approved lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb) for treatment of adults with relapsed or refractory large B-cell lymphoma after one prior therapy. Read more.
8. On June 8, the FDA granted regenerative medicine advanced therapy designation to ALLO-501 (Allogene Therapeutics), a chimeric antigen receptor T-cell therapy, for the treatment of adults with relapsed or refractory large B-cell lymphoma. Read more.
9. On May 28, the FDA granted accelerated approval to tisagenlecleucel (Kymriah, Novartis) for treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Read more.
10. On April 19, the FDA granted fast track designation to ADI-001 (Adicet Bio) for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma. Read more.
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