The FDA on May 28, 2026, approved IMFINZI® with BCG for the treatment of adult patients with BCG-naïve, high-risk Non-Muscle Invasive Bladder Cancer (NMIBC). IMFINZI® is a product of AstraZeneca.
Category: FDA Approvals
DATROWAY® (Datopotamab deruxtecan-dlnk)
The FDA on May 22, 2026, approved DATROWAY® for adult patients with unresectable or metastatic Triple-Negative Breast Cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY® is a product of Daiichi Sankyo, Inc.
ENHERTU® (fam-Trastuzumab Deruxtecan-nxki; T-DXd)
The FDA on May 15, 2026, approved ENHERTU® for two separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for T-DXd followed by a taxane, Trastuzumab, and Pertuzumab (THP), for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for T-DXd for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with Trastuzumab (with or without Pertuzumab) and taxane-based treatment. ENHERTU® is a product of Daiichi Sankyo, Inc.
TECENTRIQ® (Atezolizumab) and TECENTRIQ HYBREZA® (Atezolizumab and Hyaluronidase-tqjs)
The FDA on May 15, 2026, approved TECENTRIQ® (Atezolizumab) and TECENTRIQ HYBREZA® as adjuvant treatments for adults with Muscle Invasive Bladder Cancer (MIBC) after cystectomy who have circulating tumor DNA Molecular Residual Disease (ctDNA MRD) as determined by an FDA-authorized test. TECENTRIQ® and TECENTRIQ HYBREZA® are products of Genentech, Inc.
INQOVI® (Decitabine and Cedazuridine tablets) with Venetoclax
The FDA on May 13, 2026, approved an oral combination of INQOVI® with Venetoclax for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. INQOVI® is a product of Taiho Oncology.
BEQALZI® (Sonrotoclax)
The FDA on May 13, 2026, granted accelerated approval to BEQALZI®, a BCL-2 inhibitor, for adults with relapsed or refractory Mantle Cell Lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s Tyrosine Kinase (BTK) inhibitor. BEQALZI® is a product of BeOne Medicines USA, Inc.
BIZENGRI® (Zenocutuzumab-zbco)
The FDA on May 8, 2026, approved BIZENGRI® for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a NeuReGulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy. NRG1-fusion positive cholangiocarcinoma is an extremely rare, life-threatening malignancy. BIZENGRI® is a product of Partner Therapeutics, Inc.
VEPPANU® (Vepdegestrant)
The FDA on May 1, 2026, approved VEPPANU®, a heterobifunctional protein degrader, for adults with Estrogen Rreceptor (ER)-positive, Human Epidermal growth factor Receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. VEPPANU® is a product of Arvinas Operations, Inc.
LIFYORLI® (Relacorilant)
The FDA on March 25, 2026, approved LIFYORLI®, a glucocorticoid receptor antagonist, in combination with nab-Paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included Bevacizumab. LIFYORLI® is a product of Corcept Therapeutics Inc.