FDA Accelerates Approvals for Oncology Drugs for Various Cancer Types

Lisocabtagene Maraleucel (Breyanzi) Gets FDA Approval for Mantle Cell Lymphoma

Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor T-cell therapy, has been approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The approval came after the treatment showed positive results in clinical trials, where 87% of patients responded to the treatment and 62% achieved a complete response. Mantle cell lymphoma is a rare but aggressive form of non-Hodgkin’s lymphoma that is difficult to treat.

Nutcracker Therapeutics Inc. Presents NTX-472 for B Cell Lymphoma at ASCO

Nutcracker Therapeutics Inc., a biotechnology company focused on developing RNA therapies, presented a poster on NTX-472, its new preclinical drug candidate for B cell lymphoma, at the 2024 American Society of Clinical Oncology Annual Meeting in Chicago. The drug candidate targets a specific protein on cancer cells, making it a more targeted therapy that reduces the risk of damage to healthy cells. The preclinical trial results showed a significant reduction in tumor size and increased survival rates in animal models.

Repotrectinib (Augtyro) FDA Approved for Solid Tumors with Neurotrophic Tyrosine Receptor Kinase Gene Fusion

The FDA granted accelerated approval to repotrectinib (Augtyro) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion, are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy. The approval came after the treatment showed positive results in clinical trials, where tumor reduction was observed in 58% of patients with an overall response rate of 67%. The drug targets a gene fusion that is responsible for the growth and spread of cancer cells, making it a more effective and targeted therapy.

Harpreet Singh Joins Precision for Medicine as Chief Medical Officer

Harpreet Singh, former division director of oncology at FDA, has joined Precision for Medicine, a clinical research organization, as chief medical officer. Her role is to oversee medical strategy and ensure that the company stays at the forefront of clinical innovation by adopting new technologies and expanding its research into new areas. Singh brings a wealth of experience in oncology, having been involved in the approval of several oncology drugs during her time at the FDA.

Imetelstat (Rytelo) FDA Approved for Myelodysplastic Syndromes

The FDA approved Geron Corporation’s, imetelstat (Rytelo), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents. The approval came after positive results were observed in clinical trials, where patients demonstrated reduced transfusion dependence and improved overall survival rates. Myelodysplastic syndromes are a group of bone marrow disorders that lead to low blood cell counts and an increased risk of infection and bleeding.

Selpercatinib (Retevmo) Gets FDA Approval for Pediatric Patients

The FDA granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two years of age and older with advanced solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion. The approval came after positive results were observed in clinical trials, where tumor reduction was observed in 79% of patients with an overall response rate of 85%. The drug targets a gene fusion that is responsible for the growth and spread of cancer cells, making it a more effective and targeted therapy.

Should You Delete Your Healthcare Account?

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Conclusion

It’s an exciting time in oncology research, with the FDA approving new drugs and treatments that are more effective and targeted than ever before. With the approval of these drugs, patients with advanced cancers have new hope for longer and better quality of life.

Originally Post From https://cancerletter.com/drugs-and-targets/20240614_8a/

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