Oncology Newsfeed

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

FDA Approves Crizotinib for Children and YA Patients with R/R ALCL

On January 14, 2021, the U.S. Food and Drug Administration (FDA) approved crizotinib for pediatric patients 1 year of age and older and young adults (YA) with relapsed or refractory (R/R), systemic anaplastic large cell lymphoma (ALCL)  that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive  ALCL.

Read the FDA announcement.

Read Pfizer's announcement.

Posted 1/15/2021

CMS Releases C-Code for Belantamab Mafodotin-blmf

The Centers for Medicare and Medicaid Services (CMS) released the C-code C9369 (injection, belantamab mafodontin-blmf, 0.5 mg) for GlaxoSmitheKline's Blenrep (belantamab mafodotin-blmf), effective January 1, 2021.

Posted 1/5/2021

FDA Approves Osimertinib for the Adjuvant Treatment of EGFRm NSCLC

FDA Approves Relugolix for Advanced Prostate Cancer

FDA Approves Selinexor for R/R Multiple Myeloma

therapy. Selinexor was previously approved under the FDA's accelerated approval program for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.