FDA grants accelerated approval to Epkinly for R/R DLBCL and high-grade B-cell lymphoma

Angelo de Claro named acting director of FDA Oncology Center of Excellence

Angelo de Claro was named acting director of the FDA Oncology Center of Excellence, following Richard Pazdur’s departure from that position—and the agency (The Cancer Letter, Dec. 5, 2025).

Similar results reported in comparison of pirtobrutinib vs. ibrutinib to treat CLL, SLL, OSU study finds

A study led by The Ohio State University Comprehensive Cancer Center—Arthur G. James Cancer Hospital and Richard J. Solove Research Institute found the drug pirtobrutinib worked as well as another drug, ibrutinib, in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma, and people in the study responded better with pirtobrutinib.

December 19, 2025

Vol.51 No.46

Drugs & Targets

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA has approved rucaparib (Rubraca) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.

December 19, 2025

Vol.51 No.46

Drugs & Targets

FDA and OS Therapies hold Type C meeting regarding phase IIb clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

FDA and OS Therapies held a Type C meeting regarding the phase IIb human clinical trial of OST-HER2 in the prevention or delay of recurrent, fully-resected, pulmonary metastatic osteosarcoma.

December 19, 2025

Vol.51 No.46

Drugs & Targets

FDA awards National Priority Voucher to Tecvayli+Darzalex based on phase III study results

FDA has awarded a National Priority Voucher to teclistamab (Tecvayli) in combination with daratumumab (Darzalex) for relapsed/refractory multiple myeloma. This brings the total number of products receiving an award under the Commissioner’s National Priority Voucher pilot program to 16.

December 19, 2025

Vol.51 No.46

Drugs & Targets

EC approval of Minjuvi in relapsed or refractory follicular lymphoma

The European Commission has approved Minjuvi (tafasitamab) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymphoma (Grade 1-3a) after at least one line of systemic therapy.

December 19, 2025

Vol.51 No.46

FDA grants accelerated approval to Epkinly for R/R DLBCL and high-grade B-cell lymphoma

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Angelo de Claro named acting director of FDA Oncology Center of Excellence

Similar results reported in comparison of pirtobrutinib vs. ibrutinib to treat CLL, SLL, OSU study finds

FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer

FDA and OS Therapies hold Type C meeting regarding phase IIb clinical trial of OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma

FDA awards National Priority Voucher to Tecvayli+Darzalex based on phase III study results

EC approval of Minjuvi in relapsed or refractory follicular lymphoma

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