Drug Approvals

China’s National Medical Products Administration has accepted a biologics license application for trastuzumab pamirtecan (T-Pam; DB-1303), moving it closer to becoming a new second-line treatment for HER2-positive metastatic breast cancer. The application is based on a Phase 3 trial comparing T-Pam with Kadcyla. The study showed that T-Pam significantly improved progression-free survival. It also demonstrated […]

In April 2026, the FDA approved brexucabtagene autoleucel for patients with relapsed or refractory mantle cell lymphoma (MCL), offering the potential for long-term remissions, according to Lore Gruenbaum. The decision was based on results from the ZUMA-2 trial, which showed high response rates across patient groups. In earlier-line patients, the overall response rate was 91%

In February 2026, the U.S. Food and Drug Administration approved an all-oral combination of acalabrutinib and venetoclax for patients with CLL or SLL, marking the first U.S. approval of a BTK inhibitor plus a BCL-2 inhibitor in a pill-only regimen. The Phase 3 AMPLIFY trial showed improved outcomes over chemoimmunotherapy, with 76.5% of patients progression-free

The FDA has granted Breakthrough Therapy Designation to plixorafenib (FORE8394) for adults with BRAF V600E–mutated high-grade glioma, aiming to speed up its development and review. Plixorafenib is an oral, next-generation BRAF inhibitor designed to work on multiple BRAF mutations while reducing side effects compared with earlier drugs. Early trials show a 67% overall response rate

The FDA has given full approval to brexucabtagene autoleucel (Tecartus) for adults with relapsed or refractory mantle cell lymphoma (MCL), upgrading its previous accelerated approval. This decision is based on data from the ZUMA-2 trial, including patients who had not yet received BTK inhibitors. In this group, Tecartus showed a 91% overall response rate and

The U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy (RMAT) designation to CB-011, a next-generation CAR T-cell therapy developed by Caribou Biosciences for patients with relapsed or refractory multiple myeloma. In an early clinical trial, CB-011 showed strong results. Among 12 previously untreated patients, 92% responded to the therapy. About 75% achieved

Cogent Biosciences has submitted a new drug application to the U.S. Food and Drug Administration for bezuclastinib to treat patients with gastrointestinal stromal tumors (GIST) who have already been treated with imatinib. The application is for bezuclastinib used together with sunitinib. In the Phase 3 PEAK trial, the combination showed clear benefits. Patients receiving both

The U.S. Food and Drug Administration reported major oncology updates in March 2026, highlighting advances in precision treatment and imaging. For advanced Hodgkin lymphoma, Nivolumab plus AVD is now approved as first-line therapy, improving outcomes over older regimens. In ovarian cancer, Relacorilant with chemotherapy was approved for platinum-resistant disease, cutting the risk of death by

The U.S. Food and Drug Administration has granted Priority Review to lirafugratinib, an oral FGFR2 inhibitor, for patients with pretreated cholangiocarcinoma carrying FGFR2 fusions or rearrangements. A regulatory decision is expected by September 27, 2026. In the Phase 1/2 ReFocus trial, 114 FGFR inhibitor–naive patients showed a 46.5% objective response rate, including 2.6% complete responses,

The U.S. Food and Drug Administration approved denosumab-adet as a biosimilar to denosumab, expanding treatment options for osteoporosis and bone loss. The drug is approved for all the same uses as Prolia, including treating osteoporosis in high-risk men and postmenopausal women, managing bone loss caused by long-term steroid use, and increasing bone mass in patients