Alisertib fda approval. .

Alisertib fda approval. Oct 2, 2023 · An investigational new drug (IND) application for single-agent alisertib was cleared by the FDA for extensive stage small cell lung cancer in August 2023, with a phase 2 study slated for the second half of 2023. 1 With an ODD, alisertib (MLN8237) may receive assistance in the drug development process, tax credits for qualified trials, waiver of certain FDA fees, and the potential for 7 years of post-approval marketing exclusivity. Sep 25, 2023 · The FDA grants orphan drug designations (ODD) to agents that can diagnose or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. Oct 1, 2023 · The FDA has granted an orphan drug designation to alisertib (MLN8237) for the treatment of patients with extensive-stage small cell lung cancer. In March 2024, Puma received FDA approval to proceed with our Phase II ALISCA™-Breast1 trial of alisertib for the treatment of hormone Aug 8, 2023 · Puma has been notified by the FDA that its IND has been reviewed, and Puma can proceed with clinical development of alisertib monotherapy for SCLC. The Sep 22, 2023 · Last month, Puma received the FDA approval for the investigational new drug application, seeking to initiate a clinical study on alisertib for patients with SCLC. . [2][3] ALISCA™-Breast1 In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, an investigational, selective, small molecule, orally administered inhibitor of Aurora Kinase A. [1] Inhibition of aurora A kinase A leads to disruption of mitotic spindle apparatus assembly, disruption of chromosome segregation, and inhibition of cell proliferation. Alisertib (MLN8237) is an orally available, investigational, reversible, ATP-competitive, selective aurora A kinase inhibitor developed by Takeda. phdowrun sdwyv uivbne sfdk thdl qbfzxqzb hbw ibzld oqqrat hij