Oncology Newsfeed

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

FDA Approves Daratumumab and Hyaluronidase-fihj in Combination for MM

On November 30, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (MM) who have received one to three prior lines of therapy.

Read the FDA announcement.

Read Janssen, Inc.'s announcement.

Posted 12/2/2021

Updates to Roundtable on CMS Innovation Center Health Equity Strategy

FDA Approves Pafolacianine for the Detection of Ovarian Cancer Lesions

FDA Approves Sirolimus Protein-Bound Particles for PEComa

On Novemeber 23, 2021, the U.S. Food and Drug Administration (FDA) approved sirolimus protein-bound particles for injectable suspension (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Read Aadi Bioscience, Inc.'s announcement.

Posted 11/23/2021

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021

U.S. MSTF Releases New Colorectal Cancer Screening Recommendation

On Monday, November 15, 2021, the United States Multi-Society Task Force (MSTF) on Colorectal Cancer released updated screening recommendations. The Task Force now suggests that colorectal cancer screening starts in average-risk individuals age 45 to 49. This update is aligned with multiple other professional societies, including the United States Preventative Services Task Force, National Comprehensive Cancer Network, and American Cancer Society.

Unchanged recommendations from their 2017 update include:

• Strong recommendation for colorectal cancer screening in all individuals age 50 to 75 who have not already initiated screening.
• For individuals age 75 to 85, the decision to start or continue screening should be based on prior screening history, comorbidity, life expectancy, colorectal cancer risk, and personal preference.
• Screening is not recommended for individuals after age 85.
  

The Multi-Society Task Force on Colorectal Cancer is represented by the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy.

Full recommendations were published online via Gastrointestinal Endoscopy, Gastroenterology, and The American Journal of Gastroenterology. All articles will be available in January 2022 print issues.

Posted 11/16/2021

FDA Approves Ropeginterferon Alfa-2b-NJFT for Polycythemia Vera

On November 12, 2021, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.

Read the FDA announcement.

Read PharmaEssentia's announcement for more information.

Posted 11/15/2021

CMS Releases Final Rule to the Radiation Oncology Model

On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released the CY 2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems final rule (CMS-1753-F). This announcement includes the finalized modifications to the Radiation Oncology (RO) Model.

The RO Model is set to begin January 1, 2022, and end December 31, 2026. The proposed rule includes the summarized modifications below:

• Adjustment to the pricing methodology (updated baseline period is 2017 to 2019 and lowered discounts to 3.5 and 4.5) for the professional component and technical component, respectively
• Removal of brachytherapy from included modalities
• Removal of liver cancer from included cancer types
• Finalization of cases in which a beneficiary switches from traditional fee-for-service (FFS) to Medicare Advantage during an episode and before treatment is complete. CMS will consider this an incomplete episode and radiation therapy services will be paid under FFS.
• Modification to the current Pennsylvania Rural Health Model (PARHM) overlap policy to only exclude hospitals participating in the model, no just PARHM-eligible hospitals
• Addition of an overlap policy for the Community Track of the CHART Model
• Addition of an extreme and uncontrollable circumstances policy.

For additional information on the RO Model and CMS' final rules, visit the RO Model website or read more on thefinal rule. For questions on the model or for participants needing their model ID, contact RadiationTherapy@cms.hhs.gov.

Posted 11/3/2021

FDA Grants Accelerated Approval to Asciminib for Chronic Myeloid Leukemia

On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.

Read the FDA announcement.

Read Novartis' announcement.

Posted 11/1/2021