Oncology Newsfeed

FDA Approves Dostarlimab-gxly for dMMR Recurrent or Advanced Solid Tumors

On August 17, 2021, the U.S. Food and Drug Administration (FDA) approved a second indication for dostarlimab-gxly for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced solid tumors—as determined by an FDA-approved test—that have progressed on or following prior treatment and who have no satisfactory alternative treatment options.

Read the FDA announcement.

Read GlaxoSmithKline's announcement.

Posted 8/18/2021

FDA Approves Belzutifan for von Hippel-Lindau Disease-Associted Tumors

On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.

Read the FDA announcement.

Read the Merck announcement.

Posted 8/16/2021

FDA Approves Levnatinib + Pembrolizumab for Advanced RCC

On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).

Read the FDA announcement.

Read the Eisai announcement.

Posted 8/16/2021

FDA Approves Pembrolizumab for High-Risk, Early-Stage TNBC

On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Read Merck's announcement.

Posted 7/27/2021

FDA Approves Pembrolizumab + Lenvatinib for Advanced Endometrial Cancer

On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation. 

Read the FDA announcement.

Read the Merck announcement.

Read the Eisai Inc. announcement. 

Posted 7/22/2021

CMS Releases Notice of Proposed Rulemaking for the RO Model

The proposed CY2022 OPPS/ASC rules include the following RO Model proposals:

• Changing the baseline period from 2016-2018 to 2017-2019.
  
• Lowering the discount to 3.5 percent for the professional component and to 4.5 percent for the technical component.
• Removing brachytherapy from the list of included modalities, which would still be paid by fee-for-service.
• Proposing that in cases where a beneficiary switches from traditional Medicare to Medicare Advantage during an episode before treatment is complete, CMS would consider this an incomplete episode and RT services will be paid by the traditional Medicare rate.
• Adding an extreme and uncontrollable circumstances policy to give flexibility to reduce administrative burden of Model participation, including reporting requirements, and/or adjust the payment methodology as necessary when extreme and uncontrollable circumstances exist.
• Removing liver cancer from the Model.

Read the full CMS Notice online. For more information on the RO Model, visit its website.

Posted 7/20/2021

FDA Approves Belumosudil for Chronic GVHD

On July 16, 2021, the U.S. Food and Drug Administration (FDA) approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.

Read the FDA announcement.

Read the Kadmon Holdings, Inc. announcement.

Posted 7/19/2021

FDA Approves Daratumumab and Hyaluronidase-fihj in Combination for MM

On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma (MM) who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.

Read the FDA announcement.

Read Janssen's announcement.

Posted 7/12/2021

FDA Grants Regular Approval + New Indication to Enfortumab Vedotin-ejfv

FDA Approves Expanded Indication for Pembrolizumab for cSCC