by Jakub Jarolím, Business Intelligence Department
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Sotio Biotech
10/7/2024
June 2024 Biotechnology: Review of news from the most innovative therapeutic areas and the business development transactions
Market
Fed has no intention of lowering rates any time soon as inflation remains high
The Nasdaq Biotech Index added 3 % during June, but long-term trend remains flat. The Fed has no intention of lowering rates any time soon as inflation remains high and also such action would likely require that labor markets weaken significantly.
Antibody-Drug Conjugates
Patritumab deruxtecan BLA submission received complete response letter from FDA
FDA has issued a Complete Response Letter for the BLA seeking accelerated approval of Daiichi Sankyo and Merck’s patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with two or more systemic therapies.
Interleukin-15 and Interleukin-2
ImmunityBio announced insurance coverage of Anktiva across multiple states
ImmunityBio announced the initial treatment of multiple patients in the United States to receive therapy with Anktiva (nogapendekin alfa inbakicept-pmln), ImmunityBio’s recently approved immunotherapy for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ.
Cell Therapies
Breyanzi demonstrated clinically meaningful outcomes in broad range of B-cell cancers
BMS announced data from three studies evaluating Breyanzi (liso-cel), including long-term data with three-year follow-up from the Phase 3 TRANSFORM trial of Breyanzi as a second-line treatment in patients with relapsed or refractory LBCL, results from a subgroup analysis evaluating the efficacy and safety of Breyanzi by number of prior lines of therapy in the mantle cell lymphoma (MCL) cohort of the TRANSCEND NHL 001 trial, and results from a subgroup analysis assessing the efficacy and safety of Breyanzi based on use of bridging therapy in the TRANSCEND FL trial in relapsed or refractory follicular lymphoma (FL).
Other Innovative Treatment Areas
FDA approved Blincyto in CD19-positive Philadelphia chromosome-negative B-ALL
Amgen announced the FDA has approved Blincyto (blinatumomab) for the treatment of adult and pediatric patients one month or older with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of measurable residual disease (MRD) status.
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