The FDA on August 5, 2022, approved NUBEQA® tablets in combination with Docetaxel for adult patients with metastatic Hormone-Sensitive Prostate Cancer (mHSPC). NUBEQA® is a product of Bayer HealthCare Pharmaceuticals Inc.
The FDA on August 5, 2022, approved ENHERTU® for adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting, or developed disease recurrence during or within six months of completing adjuvant chemotherapy. ENHERTU® is a product of Daiichi Sankyo, Inc.
The FDA on June 24, 2022, approved BREYANZI® (Lisocabtagene maraleucel) for adult patients with Large B-Cell Lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy, or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for Hematopoietic Stem Cell Transplantation (HSCT) due to comorbidities or age. It is not indicated for the treatment of patients with primary Central Nervous System lymphoma. BREYANZI® is a product of Juno Therapeutics, Inc.
The FDA on June 22, 2022, granted accelerated approval to TAFINLAR® (Dabrafenib) in combination with MEKINIST® (Trametinib) for the treatment of adult and pediatric patients 6 years of age or older with unresectable or metastatic solid tumors with BRAF V600E mutation, who have progressed following prior treatment, and have no satisfactory alternative treatment options. TAFINLAR® and MEKINIST® are products of Novartis Pharmaceuticals Corporation.
OPDIVO® and YERVOY® are products of Bristol-Myers Squibb Company
The FDA on May 25, 2022, approved TIBSOVO® (Ivosidenib) in combination with Azacitidine (Azacitidine for injection) for newly diagnosed Acute Myeloid Leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. TIBSOVO® is a product of Servier Pharmaceuticals LLC.
The FDA on May 4, 2022, approved ENHERTU® for adult patients with unresectable or metastatic HER2-positive breast cancer, who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within 6 months of completing therapy. ENHERTU® is a product of Daiichi Sankyo, Inc.