Oncology Newsfeed

FDA Approves Avelumab for Maintenance Treatment in Advanced Urothelial Carcinoma

On June 30, 2020, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio, EMD Serono, Inc.) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.

Read FDA announcement.

Posted 7/1/2020

FDA Approves Pembrolizumab for First-line Treatment of Metastatic MSI-H or dMMR CRC

On June 29, 2020, the U.S. Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

Read FDA announcement.

Posted 6/30/2020

FDA Approves New Fixed-Dose Combination for HER2+ Breast Cancer

On June 29, 2020, the U.S. Food and Drug Administration approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase–zzxf (Phesgo, Genentech, Inc.) for subcutaneous injection for the following indications: 

• Use in combination with chemotherapy as: 
  • neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer;
  • adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.
• Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
  

CMS Releases Preliminary Data on Impact of COVID-19 on Medicare Population

On June 23, the Centers for Medicare & Medicaid Services (CMS) released a preliminary snapshot of the COVID-19 pandemic's impact on the Medicare population, based on Medicare claims data.

The data released today includes the total number of reported COVID-19 cases and hospitalizations among Medicare beneficiaries between January 1 and May 16, 2020. The snapshot breaks down COVID-19 cases and hospitalizations for Medicare beneficiaries by state, race/ethnicity, age, gender, dual eligibility for Medicare and Medicaid, and urban/rural locations.

CMS data shows that more than 325,000 Medicare beneficiaries received a diagnosis of COVID-19 between January 1 and May 16, 2020. During this same time period, nearly 110,000 Medicare beneficiaries were hospitalized for COVID-19-related treatment. According to the CMS snapshot released today, Black Medicare beneficiaries were hospitalized with COVID-19 at a rate nearly four times higher than whites.

CMS data shows that:

• End-stage renal disease (ESRD) patients had the highest rate of hospitalization among all Medicare beneficiaries, with 1,341 hospitalizations per 100,000 beneficiaries.
• The second highest rate was among beneficiaries enrolled in both Medicare and Medicaid (also known as “dual eligible”), with 473 hospitalizations per 100,000 beneficiaries.
• Among racial/ethnic groups, Blacks had the highest hospitalization rate, with 465 per 100,000. Hispanics had 258 hospitalizations per 100,000. Asians had 187 per 100,000 and whites had 123 per 100,000.
• Beneficiaries living in rural areas have fewer cases and lower rates of hospitalization than Medicare beneficiaries living in urban/suburban areas (57 versus 205 hospitalizations per 100,000).

CMS Announces New Office of Burden Reduction and Health Informatics

FDA Approves Selinexor for R/R Diffuse Large B-Cell Lymphoma

FDA Approves Tazemetostat for R/R Follicular Lymphoma

On June 18, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tazemetostat (Tazverik, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies, and for adult patients with R/R FL who have no satisfactory alternative treatment options.

On the same day, the FDA also approved the cobas EZH2 Mutation Test (Roche Molecular Systems, Inc.) as a companion diagnostic for tazemetostat.

Read FDA announcement.

Posted 6/18/2020

CMS: Medicaid NPRM Aims to Foster VBP Models for Prescription Drugs

The agency states that the proposals put forward support state flexibility to enter innovative value-based purchasing arrangements (VBPs) with drug manufacturers for new expensive therapies, and to provide manufacturers with regulatory flexibility to enter into VBPs with commercial payers, which will benefit Medicaid programs. The proposed rule also creates minimum standards in state Medicaid Drug Utilization Review (DUR) programs designed to reduce opioid-related fraud, misuse and abuse.

Read the CMS fact sheet on the proposed rule.  

Access the proposed rule. 

Read HealthAffairs blog by CMS Administrator Seema Verma.

Posted 6/17/2020

FDA Approves Pembrolizumab for Treatment of TMB-H Solid Tumors

On June 16, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

On the same day, the FDA also approved the FoundationOneCDx assay as a companion diagnostic for pembrolizumab.

Read the FDA announcement.

Posted 6/17/2020

FDA Extends Indication of Gemtuzumab Ozogamicin to CD33-Positive AML Pediatric Patients

On June 16, 2020, the U.S. Food and Drug Administration (FDA) extended the indication of gemtuzumab ozogamicin (Mylotarg™, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older.

Read FDA announcement.

Posted 6/16/2020