FDA News Appears Elsewhere on Clinical Oncology News Website

FDA approvals and other FDA news now appear in the other sections on the Clinical Oncology News website: Solid Tumors, Hematologic Malignancies, Community Oncology and Current Practice. 

JANUARY 8, 2025

Tukysa Approved for RAS Wild-Type, HER2-Positive Unresectable or Metastatic Colorectal Cancer

The FDA granted accelerated approval for tucatinib (Tukysa, Seagen) in combination with trastuzumab for adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed after treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

JANUARY 20, 2023

Brukinsa Approved for Leukemia Subtypes

Zanubrutinib (Brukinsa, BeiGene) has been approved by the FDA for the treatment of adult patients with chronic lym-phocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

JANUARY 20, 2023

FDA Approves Lunsumio to Treat Relapsed/Refractory Follicular Lymphoma

The FDA approved mosunetuzumab-axgb (Lunsumio, Genentech) for the treatment of adults with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

JANUARY 3, 2023

FDA Approves Adstiladrin, First Gene Therapy for Bladder Cancer

Adstiladrin is the first gene therapy for adults with high-risk bacillus Calmette-Guérin-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ with or without papillary tumors. 

DECEMBER 21, 2022

New Approvals For GVHD Expand Treatment Options

For years, therapeutic options for graft-versus-host disease had been limited. Now that there are new choices, clinicians will need to determine how the agents fit into the armamentarium for this challenging condition.

DECEMBER 19, 2022

FDA Grants Approval to Krazati for KRAS G12C-Mutated NSCLC

The FDA has granted accelerated approval to adagrasib (Krazati, Mirati), a RAS GTPase family inhibitor, for adults with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy.

DECEMBER 16, 2022

Libtayo Gains New NSCLC Indication

The FDA approved the programmed death-1 inhibitor cemiplimab-rwlc (Libtayo, Regeneron) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer with no ALK, EGFR or ROS1 aberrations. 

NOVEMBER 28, 2022

FDA Approves Elahere to Treat Platinum-Resistant Ovarian Cancer

Mirvetuximab soravtansine-gynx (Elahere, ImmunoGen) was approved to treat adults with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. 

NOVEMBER 23, 2022

Adcetris Gets New Indication

The FDA approved brentuximab vedotin (Adcetris, Seagen) for the treatment of pediatric patients aged 2 years and older with previously untreated high-risk classic Hodgkin lymphoma (HL), in combination with doxorubicin, vincristine, etoposide, prednisone and cyclophosphamide. 

NOVEMBER 16, 2022

New Treatment for Unresectable Hepatocellular Carcinoma

The FDA has approved AstraZeneca’s tremelimumab (Imjudo, AstraZeneca) in combination with durvalumab (Imfinzi, AstraZeneca) for the treatment of adults with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.

OCTOBER 24, 2022

Lytgobi Approved for Certain Patients With Advanced Intrahepatic Cholangiocarcinoma

OCTOBER 3, 2022