FDA Grants Accelerated Approval to Lilly Cancer Drug
FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.
FDA announced on Jan. 27, 2023, that it has granted accelerated approval to Eli Lilly and Company for Jaypirca (pirtobrutinib) as a treatment for relapsed or refractory mantle cell lymphoma (MCL). Patients who have had at least two lines of systemic therapy, including a bruton tyrosine kinase (BTK) inhibitor, are eligible for the treatment.
Efficacy for pirtobrutinib was evaluated in an open-label, multicenter, single-arm trial (BRUIN [NCT03740529]) of pirtobrutinib monotherapy that included 120 patients with MCL previously treated with a BTK inhibitor. Pirtobrutinib was administered orally at 200 mg once daily and was continued until disease progression or unacceptable toxicity. The main efficacy measures were overall response rate (ORR) and duration of response (DOR). In the results, ORR was measured to be 50%, median DOR was 8.3 months, and the estimated DOR rate at six months was 65.3%.
According to the agency press release, the recommended pirtobrutinib dosage is 200 mg orally once daily until disease progression or unacceptable toxicity. Prior to this accelerated approval, pirtobrutinib received priority review, fast track, and orphan drug designations.
Source: FDA
Benuvia Granted GMP Certification by Brazil National Health Surveillance Agency
March 14th 2025The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
