Drug Approvals

The FDA has approved Ennumo (pegfilgrastim-pccg), a biosimilar to Neulasta (pegfilgrastim), for adults and children. Developed by Accord BioPharma, it is the eighth pegfilgrastim biosimilar approved in the United States. The drug is supplied as a single-dose prefilled syringe and helps reduce the risk of infection by increasing white blood cell production in patients receiving […]

The FDA has expanded the approval of pembrolizumab (Keytruda) or the subcutaneous formulation Keytruda Qlex, in combination with enfortumab vedotin (Padcev), for adults with muscle-invasive bladder cancer (MIBC). The regimen can now be used before surgery (neoadjuvant therapy) and after bladder removal surgery (adjuvant therapy) for all patients who are eligible for surgery, regardless of

The FDA has approved a subcutaneous (under-the-skin) formulation of isatuximab-irfc (Sarclisa Escena) for all indications previously covered by the intravenous (IV) version in multiple myeloma. The treatment can be administered using the wearable CirCLIQ on-body delivery system or a manual syringe, making it the first FDA-approved cancer therapy delivered through an on-body injector. The approval

China has conditionally approved savolitinib (Orpathys), an oral targeted MET inhibitor, for patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with MET amplification whose disease has progressed after at least two previous lines of treatment. It is the first selective MET inhibitor approved in China for this patient group. The approval

The FDA has approved the combination of belzutifan (Welireg) and pembrolizumab (Keytruda) as adjuvant treatment for patients with high-risk clear cell renal cell carcinoma (ccRCC) after surgery, establishing a new standard of care. The approval is based on the phase 3 LITESPARK-022 trial, which showed the combination reduced the risk of cancer recurrence or death

The European Union has approved trastuzumab deruxtecan (Enhertu) as a single treatment for adults with advanced or metastatic HER2-positive (IHC 3+) solid tumors. The approval covers patients whose cancer has progressed after previous treatments and who have no satisfactory treatment options. Because it is a tumor-agnostic approval, the drug can be used regardless of where the cancer started

The FDA has approved Trodelvy for two first-line treatment options in adults with advanced or metastatic triple-negative breast cancer (TNBC). Trodelvy can now be used alone for patients who are not eligible for PD-1 or PD-L1 inhibitor therapy. It is also approved in combination with Keytruda for patients whose tumors have high PD-L1 expression. The

China’s National Medical Products Administration has approved izalontamab brengitecan for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) whose disease has progressed after platinum-based chemotherapy and immunotherapy. The approval is a major milestone, making iza-bren the world’s first approved bispecific antibody-drug conjugate (ADC). The decision is based on results from the phase 3 PANKU-NPC01 Trial,

The FDA has approved the use of Ibrance (palbociclib) together with trastuzumab, with or without pertuzumab, plus hormone therapy as a maintenance treatment for adults with hormone receptor–positive, HER2-positive advanced or metastatic breast cancer after initial treatment. The approval is based on results from the phase 3 PATINA Trial, which enrolled 518 patients. The study

The European Commission has approved the antibody-drug conjugate Trodelvy as a first-line treatment for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not eligible for PD-(L)1 inhibitor therapy. The approval is based on results from the Phase 3 ASCENT-03 trial, which showed that Trodelvy reduced the risk of disease progression or death