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...
Palbociclib is the first CDK4/6 inhibitor approved for HR-positive, HER2-positive advanced breast cancer. The U.S. Food and Drug Administration (FDA) has approved palbociclib (Ibrance) in combination with trastuzumab (Herceptin), with or without pertuzumab (Perjeta),...
Afamitresgene autoleucel was granted full approval with an expanded indication for certain adult and pediatric patients with advanced synovial sarcoma. The U.S. Food and Drug Administration (FDA) has granted full approval to afamitresgene autoleucel...
The FDA approved capivasertib with abiraterone and prednisone for adults whose metastatic prostate cancer may be sensitive to hormone therapy. The U.S. Food and Drug Administration (FDA) has approved capivasertib (Truqap) with abiraterone and...
Under new approval, the drug can be given with immunotherapy to help reduce risk of recurrence after surgery in patients with clear cell renal cell carcinoma. The U.S. Food and Drug Administration (FDA) has...
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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