FDA Approves Avelumab for Rare Skin Cancer
On March 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer.
Read the FDA announcement here.
FDA Approves Keytruda® For Classical Hodgkin Lymphoma
The U.S. Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab, Merck), an anti-PD-1 (programmed death receptor-1) therapy, for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after three or more prior lines of therapy.
Read the corporate press release here.
FDA Approves Kisqali® For Metastatic Breast Cancer
The U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011, Novartis) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.
Read the corporate press release here.
Republicans Reveal Plans for Repeal and Replace of ACA
The budget resolution passed by the House in January outlined specific instructions for the Ways and Means and Energy and Commerce Committees—the primary Committees with jurisdiction over healthcare—to draft legislative recommendations that the Budget Committee could compile into one reconciliation package, the American Health Care Act.
To read the entire bill, including legislative recommendations from the Energy and Commerce and Ways and Means Committees, click here.
Walgreens Designates Specialty Pharmacies as Cancer-Specialized Locations
Walgreens announced that the company has designated more than 50 of its local specialty pharmacies as cancer-specialized locations. These cancer-specialized locations are to be led by pharmacists and pharmacy technicians who have advanced cancer training to assist patients.
The pharmacy staff at these locations have completed a cancer-focused curriculum of advanced education courses, focused on colorectal, lung, prostate and breast cancer, as well as various blood cancers such as leukemia, lymphomas, multiple myeloma, myeloproliferative neoplasms, and myelodysplatic syndrome.
Read the press release here.
FDA Approves Lenalidomide for Multiple Myeloma Following Autologous Stem Cell Transplant
On Feb. 22, 2017, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
In 2006, lenalidomide, an orally administered thalidomide analogue, received FDA approval for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy. In 2015, the indication was expanded for use in combination with dexamethasone for the treatment of patients with multiple myeloma, to include newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved in myelodysplastic syndromes and mantle cell lymphoma.
CMS Awards Approximately $100 Million to Small Practices in Quality Payment Program
The Centers for Medicare & Medicaid Services (CMS) awarded approximately $20 million to 11 organizations for the first year of a five-year program to provide training and education about the Quality Payment Program for clinicians in individual or small group practices of 15 clinicians or fewer.
Over the remaining four years, CMS intends to invest up to an additional $80 million. These community-based organizations will provide hands-on training to help small practices, especially those in historically under-resourced areas. The training and education resources will be available immediately, nationwide, and provided at no cost to eligible clinicians and practices.
FDA Approval for Opdivo in Previously Treated Urothelial Carcinomas
The U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.
HHS Withdraws 340B "Mega-Guidance”
On Jan. 30, 2017, the White House Office of Management and Budget (OMB) marked the final 340B guidance document as withdrawn and sent it back to the Department of Health and Human Services (HHS).
The proposed guidance defined who is considered a patient for purposes of the 340B drug program and also covers drug company responsibilities, such as procedures for issuing credits and refunds. The 340B program helps safety-net providers such as hospitals obtain discounted drugs. In order to advance, the guidance would now need to be resubmitted to the OMB.
However, it could be more difficult to implement the guidance due to the recent Executive Order declaring that for every new regulation or guidance introduced, two must be eliminated.
Source: BNA Healthcare
FDA Approves Imbruvica for Marginal Zone Lymphoma Patients
The U.S. Food and Drug Administration (FDA) has approved Imbruvica® (ibrutinib) for the treatment of patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. Accelerated approval was granted for this indication based on overall response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ACCC Advocates for Community Oncology at the White House and on Capitol Hill
On Jan. 11, 2017, the Association of Community Cancer Centers (ACCC) joined with leading cancer organizations in discussions at the White House and on Capitol Hill that focused on issues and challenges facing community oncology and to advocate for access to care for patients in the communities where they live.
At the White House Making Health Care Better: Community Oncology event on Wednesday morning, ACCC President Jennie R. Crews, MD, MMM, FACP, and ACCC Governmental Affairs Committee member William Holden, MBA, RT(T)(R), FACHE, participated in a panel on Addressing Disparities. On behalf of the Cancer Moonshot initiative, the event explored critical aspects of community oncology including cancer disparities, survivorship and support services, advancing clinical trials, and innovative models of care delivery in the community setting.
On Capitol Hill, ACCC co-sponsored an afternoon briefing on Innovation and Access in Quality Cancer Care. Advocates heard a panel discussion and comments from patients, providers, the Centers for Medicare & Medicaid Services, and the Cancer Moonshot Task Force. Co-sponsoring the briefing along with ACCC were the Cancer Support Community, the American Cancer Society Cancer Action Network, the Community Oncology Alliance, McKesson Specialty Health, Sarah Cannon, and The US Oncology Network.