The new agent was approved in combination with daratumumab and hyaluronidase-fihj and dexamethasone for patients with resistant or refractory disease. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to iberdomide (Zenbexus)...
Vusolimogene oderparepvec-wtpg and nivolumab earned accelerated approval to treat patients with advanced melanoma after PD-1 therapy. The U.S. Food and Drug Administration (FDA) has granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev) in combination with...
Lutetium Lu 177 vipivotide tetraxetan is the first radioligand therapy approved for metastatic prostate cancer that responds to hormone treatment. The U.S. Food and Drug Administration (FDA) has approved lutetium Lu 177 vipivotide tetraxetan...
Zidesamtinib, a next-generation ROS1 inhibitor, was approved for ROS1-positive NSCLC previously treated with ROS1 inhibition. The U.S. Food and Drug Administration (FDA) has approved zidesamtinib (Jideytro), a next-generation ROS1 inhibitor, for adults with locally...
Gedatolisib received its first FDA approval for advanced HR-positive, HER2-negative breast cancer without mutations in PIK3CA. The U.S. Food and Drug Administration (FDA) has approved gedatolisib (Revtorpyk) in combination with fulvestrant (Faslodex), with or...
The RET inhibitor received traditional approval to treat RET-fusion-positive solid tumors. The U.S. Food and Drug Administration (FDA) has granted full approval to selpercatinib (Retevmo) to treat RET-fusion-positive solid tumors in adult and pediatric...
FDA approves pembrolizumab and enfortumab vedotin-ejfv for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex)...
The FDA approved isatuximab-irfc as part of three different combination regimens for multiple myeloma. The U.S. Food and Drug Administration (FDA) has approved isatuximab-irfc (Sarclisa Escena) for subcutaneous injection for three multiple myeloma indications:...
The allogeneic regulatory T cell therapy was designed to improve HSCT outcomes in patients with hematological malignancies. The U.S. Food and Drug Administration (FDA) has approved allogeneic regulatory T cell-based immunotherapy with hematopoietic stem...
Sacituzumab govitecan-hziy was approved as a monotherapy or in combination with pembrolizumab. The U.S. Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy) for two indications in adult patients with unresectable locally advanced...
AACR Fellow Lewis C. Cantley, PhD, leads a national effort targeting triple-negative breast cancer and ovarian cancer with a novel drug combination.
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