Oncology Newsfeed

FDA Approves Amivantamab-vmjw for Subset of NSCLC

On May 21, 2021, the U.S. Food and Drug Administration (FDA) approved mivantamab-vmjw as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor exon 20 insertion mutations.

Read the FDA announcement.

Posted 5/21/2021

FDA Approves Nivolumab for Completely Resected Esophageal or GEJ Cancer

On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.

Read the FDA announcement.

Read the Bristol Myers Squibb announcement.

Posted 5/21/2021

USPSTF Releases Updated Colorectal Cancer Screening Guidelines

FDA Approves Pembrolizumab in Combination for HER2-Positive Gastric Cancer

On May 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma.

FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for R/R LBCL

On April 23, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl for adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma.

Read the FDA announcement.

Read ADC Therapeutics announcement.

Posted 4/26/2021

FDA Approves Companion Diagnostic for Immunotherapy Eligible Endometrial Cancer

On April 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Ventana MMR RxDx Panel for patients with advanced or recurrent endometrial cancer. Testing can identify patients eligible for treatment with dostarlimab-gxly, which was also approved by the FDA on April 22, 2021.

Read Roche's announcement.

Posted 4/23/2021

FDA Grants Accelerated Approval to Dostarlimab-gxly

On April 22, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly for adult patients with mismatch repair deficient recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen.

Read the FDA announcement.

Read the GlaxoSmithKline announcement.

Posted 4/23/2021

Amgen Launches Assistance Program for NSCLC Biomarker Testing

FDA Approves Nivolumab in Combination with Chemotherapy for Three Indications

On April 16, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab in combination with certain types of chemotherapy for the initial treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. This is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Read the FDA announcement.

Read the BMS announcement.

Posted 4/16/2021

FDA Approves Sacituzumab Govitecan-hziy for Urothelial Cancer

On April 13, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sacituzumab govitecan-hziy for patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

Read the FDA announcement.

Read the Gilead Sciences announcement.

Posted 4/14/2021