Oncology Newsfeed

FDA Approves Trilaciclib for Chemotherapy-Induced Myelosuppression in ES-SCLC

On February 16, 2021, G1 Therapeutics announced that the U.S. Food and Drug Administration (FDA) has approved "trilaciclib for injection to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). It is the first and only therapy designed to help protect bone marrow (myeloprotection) when administered prior to treatment with chemotherapy."

Read the full company announcement.

Read the FDA announcement.

Posted 2/16/2021

U.S. Hospitals Request the Reversals of the 340B-Drug and Pay Cuts Rulings

On February 11, 2021, InsideHealthPolicy announced that hospitals across the United States have asked the Supreme Court "to take up their lawsuits against the Trump administration’s Medicare Part B reimbursement cuts for 340B drugs and pay cuts for outpatient clinic visits at certain off-campus hospital facilities, alleging the U.S. Court of Appeals for the District of Columbia Circuit gave too much weight to the U.S. Department of Health and Human Services' interpretation of the statute in each situation." 

Read more on this at InsideHealthPolicy.

Posted 2/11/2021

FDA Issues EUA for Bamlanivimab and Etesevimab for COVID-19 Treatment

On February 9, 2021, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.

The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

Read the FDA announcement.

Posted 2/10/21

FDA Approves Cemiplimab-rwlc as First Immunotherapy for Advanced BCC

On February 9, 2021, the U.S. Food and Drug Administration (FDA) granted regular approval to cemiplimab-rwlc for patients with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic basal cell carxinoma previously treated with a HHI or for whom a HHI is not appropriate.

Read the FDA announcement.

Read Sanofi and Regeneron's announcements.

Posted 2/10/21

FDA Approves Lisocabtagene Maraleucel for R/R Large B-Cell Lymphoma

FDA Grants Accelerated Approval to Umbralisib for Two Indications

On February 5, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to umbralisib for the following indications:

• Adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen

• Adult patients with relapsed or refractory follicular lymphoma who have received at least three prior lines of systemic therapy.

Read the FDA announcement.

Read TG Therapeutics' announcement.

Posted 2/8/2021

FDA Approves Tepotinib for Metastatic NSCLC

On February 3, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tepotinib for adult patients with metastatic non-small cell lung cancer (NSCLC) barboring mesenchymal-epithelial transition exon 14 skipping alterations.

This indication is approved under accelerated approval based on overall response rate and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Read the FDA announcement.

Read Merck KGaA's announcement.

Posted 2/4/21

FDA Approves Nivolumab + Cabozantinib for Advanced RCC

On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma (RCC).

Read Bristol Myers Squibb's announcement.

Read the FDA announcement.

Posted 1/22/2021

NCCN Releases New Guidance on COVID-19 Vaccine for Patients with Cancer

FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Adenocarcinoma

On January 15, 2021, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal adenocarcinoma who have received a prior trastuzumab-based regimen.

Read the FDA announcement.

Read Daiichi Sankyo's announcement.

Posted 1/19/2021