Oncology Newsfeed

MedPAC Recommends Eliminating MIPS

The Medicare Payment Advisory Commission (MedPAC) voted on Jan. 11, to recommend to Congress that the Merit-based Incentive Payment System (MIPS) be scrapped. The federal advisory panel suggested replacing the quality reporting program with a Voluntary Value Program. MedPAC is an independent congressional agency established by the Balanced Budget Act of 1997 to advise the U.S. Congress on issues affecting the Medicare program.

Whether Congress will accept MedPAC's recommendation to eliminate MIPS is unknown. However, Bloomberg BNA reports that a House Energy and Commerce Committee spokesperson has indicated that the committee plans to continue work to ensure the success of MIPS.

Posted 1/19/2018

FDA Approves Olaparib for Germline BRCA-mutated Metastatic Breast Cancer

On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib tablets (Lynparza, AstraZeneca Pharmaceuticals LP), a poly (ADP-ribose) polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting.

This is the first FDA-approved treatment for patients with gBRCAm HER2-negative metastatic breast cancer. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Patients must be selected for therapy based on an FDA-approved companion diagnostic for olaparib.

Read the FDA announcement.

Posted 1/12/2018

FDA Grants Broadened Indication for Afatinib in First-Line Treatment of Certain Patients with Metastatic NSCLC

On Jan. 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

Read the FDA announcement.

Posted 1/12/2018

ACCC Mourns the Passing of Long-Time Member Marsha Fountain Woznuck, RN, MSN

he Association of Community Cancer Centers (ACCC) is deeply saddened by the passing of Marsha Fountain Woznuck, RN, MSN, on January 7, 2018. An active ACCC member for many years, she served on the ACCC Program Committee Advisory Panel (2012-2015); shared her knowledge on ACCCExchange, the association’s member listserv; and presented at ACCC and oncology state society conferences.

Marsha Fountain Woznuck began her career in the cancer field as a pediatric oncology nurse and later transitioned to cancer center administration. She served as vice president for an architecture and design firm focused on patient-centered spaces and as president of a nationally recognized cancer consulting firm.

Her expertise, commitment, and contributions to advancing the care and well-being of patients with cancer will be greatly missed.

Posted 1/10/2018

FDA Approves Denosumab for Prevention of Skeletal-related Events in Multiple Myeloma

On Jan. 5, 2018, Amgen announced that U.S. Food and Drug Administration (FDA) has approved the company's supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.

Read the corporate press release.

Posted 1/10/2018

CAP Issues Guideline to Ensure Accurate HPV Testing in Head and Neck Cancers

The College of American Pathologists (CAP) released its newest evidence-based practice guideline, "Human Papillomavirus (HPV) Testing in Head and Neck Carcinomas," on December 19, 2017.

The guideline, which recommends accurate assessment of a patient's high-risk HPV status, directly or by surrogate markers, was developed by an interdisciplinary, expert panel that included pathologists, surgeons, radiation oncologists, medical oncologists, patients, and patient advocates.

Based on a screening of 2,200 peer-reviewed articles and a review of evidence from 492 studies, the panel issued 14 final recommendations in the guideline.

Learn more on the CAP website.

Posted 1/3/2018

FDA Updates Nilotinib Label to Include Treatment Discontinuation Recommendations for CML with Sustained Molecular Responses

On December 22, 2017, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna, Novartis Pharmaceuticals Corp.) to include information on nilotinib discontinuation, post-discontinuation monitoring criteria, and guidance for treatment re-initiation in patients taking nilotinib for Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) who have achieved a sustained molecular response (MR 4.5).

Patients with newly diagnosed Ph+ CML in the chronic phase (CP) and resistant or intolerant Ph+ CML-CP patients who have achieved a sustained molecular response (MR4.5) may be considered for discontinuation after at least three years of nilotinib. To be considered for discontinuation, patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detection limit below at least MR4.5 must be used to determine discontinuation eligibility. Patients must be frequently monitored by this test to detect possible loss of remission.

Common adverse reactions in patients who discontinued nilotinib include musculoskeletal symptoms including body aches, bone pain, and extremity pain. Some patients experienced prolonged musculoskeletal symptoms. The long-term outcomes of patients discontinuing versus continuing treatment are unknown at this time.

Read the FDA announcement.

Posted 1/2/2018