Enforcement Report - Week of October 25, 2023
The addition of ibrutinib (Imbruvica) to bendamustine plus rituximab (Rituxan; BR) or R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) did not lead to a statistically significant improvement in progression-free survival (PFS) vs either chemoimmunotherapy regimen alone in patients with relapsed/refractory follicular lymphoma or marginal zone lymphoma (MZL), according to findings from the phase 3 SELENE trial (NCT01974440) presented at the 17th Annual International Conference on Malignant Lymphoma.1
PASADENA, CA, June 07, 2023 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT) (LIXTE), a clinical-stage drug discovery company developing pharmacologically active drugs for use...
An FDA committee of outside cancer experts voted 11-2 Thursday that the FDA should expand Roche’s Polivy label to include it as a treatment in combo with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
YES Pharmaceutical`s Celdoxome pegylated liposomal (doxorubicin hydrochloride) Receives Approval in Europe
Seagen’s plan to expand Adcetris’ market is on track following positive Phase II study results. Monday, the biopharma announced Adcetris hit the mark in a multi-part, midstage trial for advanced and early-stage classical Hodgkin lymphoma (cHL).
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new and updated data for its first-in-class anti-CD79b antibody-drug conjugate Polivy® (polatuzumab vedotin-piiq) were presented at the 64th American Society of Hematology (ASH) Annual Meeting & Exposition, December 10-13. Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).
SAN CARLOS, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Apexigen, Inc. (NASDAQ: APGN) a clinical-stage company focused on developing innovative antibody-based therapeutics for the treatment of cancer with a focus on immuno-oncology, today announced topline data from an ongoing Phase 2 investigator sponsored trial in collaboration with Columbia University, evaluating sotigalimab, Apexigen’s agonist antibody targeting CD40, in combination with standard of care doxorubicin (dox), in patients with advanced soft tissue sarcoma (STS). In the subgroup of patients with liposarcoma (LPS), the second most common STS, treatment with sotigalimab combined with dox resulted in a median progression-free survival (mPFS) of 12.45 months relative to the historically observed mPFS of less than 5 months in patients treated with dox monotherapy.
Celerity's Generic Doxorubicin Hydrochloride Receives Approval in the U.S.
PASADENA, CA, Oct. 13, 2022 (GLOBE NEWSWIRE) -- LIXTE Biotechnology Holdings, Inc. (Nasdaq: LIXT), (“LIXTE” or the “Company”), a clinical-stage pharmaceutical company focused on developing and commercializing cancer therapies, announced that the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) has authorized a Phase 1b/randomized Phase 2 study of LB-100, the Company’s lead clinical compound, plus doxorubicin versus doxorubicin alone, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS).