Drug Approvals

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to TERN-701, a new targeted drug for patients with Philadelphia chromosome–positive chronic myeloid leukemia who have already failed at least two prior treatments and do not carry the T315I mutation. Results from the Phase 1/2 CARDINAL trial, presented at the ASH Annual Meeting, showed […]

The U.S. Food and Drug Administration has accepted and granted Priority Review for zanidatamab (Ziihera) combined with chemotherapy, with or without tislelizumab, as a first-line treatment for HER2-positive advanced gastroesophageal cancer. A final decision is expected by August 25, 2026. The application is based on results from the HERIZON-GEA-01 trial, where the zanidatamab combination showed

In early 2016, the FDA approved several important new cancer and hematology treatments. cabozantinib (Cabometyx) was approved for advanced kidney cancer after prior therapy. In trials, it nearly doubled the time patients lived without disease progression compared to everolimus (7.4 vs. 3.8 months) and showed a median overall survival of 21.4 months. Common side effects

Australia’s Therapeutic Goods Administration has approved a new three-drug combination—tafasitamab (Minjuvi) with rituximab and lenalidomide—for adults with relapsed or refractory follicular lymphoma, following a similar decision by the U.S. Food and Drug Administration in 2025. The approval is based on a Phase 3 trial showing the combination significantly improved outcomes. Patients receiving the triplet therapy

The European Commission has granted conditional approval to tovorafenib (Ojemda) for children aged 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) carrying BRAF alterations. This is the first systemic therapy specifically approved in the EU for BRAF-rearranged pLGG. The decision is based on results from the FIREFLY-1 trial, where the drug

National Medical Products Administration has approved belantamab mafodotin with bortezomib and dexamethasone for adults with relapsed or refractory multiple myeloma after at least one prior therapy. The approval is based on the DREAMM-7 trial, where the combination significantly outperformed a standard daratumumab-based regimen. It extended progression-free survival to 36.6 months versus 13.4 months and reduced

The U.S. FDA has approved nivolumab (Opdivo) in combination with AVD chemotherapy for patients aged 12 and older with newly diagnosed advanced classical Hodgkin lymphoma. This approval expands access to a modern immunotherapy-based treatment for both adults and adolescents. Results from the SWOG 1826 trial showed the combination reduced the risk of disease progression or

The phase 3 ROSELLA study found that adding relacorilant (Lifyorli) to nab-paclitaxel (Abraxane) improves survival for patients with platinum-resistant ovarian cancer. Based on these results, the combination was approved by the U.S. Food and Drug Administration in March 2026 and is now recommended in NCCN treatment guidelines. The study showed that patients receiving the combination

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%