On September 12, the American Association for Cancer Research (AACR) released its annual Cancer Progress Report highlighting how federally funded research discoveries are fueling the development of new and even more effective ways to prevent, detect, diagnose, and treat cancer.
Key advances outlined in the AACR Cancer Progress Report 2018 include the following:
Read the full Cancer Progress Report for more information.
On Wednesday, August 29, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a memo to Medicare Part D plans that will allow these plans to implement “indication-based formulary design” starting in 2020.
Currently, if a Part D plan includes a specific drug on its formulary, the plan must cover that drug for every FDA-approved indication, or patient condition, even if the plan would otherwise instead cover a different drug for a particular indication.
The CMS memo states that if a Part D plan limits formulary coverage of a drug to certain indications, the plan must ensure that there are other therapeutically similar drugs on formulary for the drug’s non-covered indications.
The ACCC policy team is currently reviewing this policy change.
Read the CMS memo to Part D plans.
Read the agency's fact sheet.
Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.
Read the full FDA announcement here.
On August 16, 2018, the Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival.
Read the full FDA press release here.