December 2017, Vol 8, No 5

Ongoing uncertainty over cost-­sharing reduction payments and premium subsidies threatens the sustainability of the Affordable Care Act (ACA) and the implementation of various quality initiatives contained within it. Consequently, several health plans are reducing their footprint in the health insurance exchanges, further threatening the stability of the ACA.

San Francisco, CA—Therapies targeting immune responses against solid tumors have led to dramatic improvements in outcomes, but the role for immunotherapy in the treatment of acute leukemia is still being defined.

San Francisco, CA—After nearly 40 years of negligible drug development, in 2017 the FDA approved 4 drugs for acute myeloid leukemia (AML). These novel therapies have been shown to decrease relapse rates, improve response rates in patients with specific mutations, and reduce short- and long-term adverse reactions asso­ciated with current treatment strategies.

Chicago, IL—Treatment with nivolu­mab (Opdivo) led to durable responses and stable disease in a majority of women with relapsed or metastatic cancers caused by human papillomavirus (HPV) infection, according to the results of a phase 1/2 clinical trial—CheckMate-358.

San Francisco, CA—Recent advances in the treatment of patients with multiple myeloma have dramatically altered the trajectory of the disease, as providers now have several efficacious agents in various drug classes at their disposal. At the 2017 NCCN Hematologic Malignancies Congress, Shaji K. Kumar, MD, Division of Hematology, Mayo Clinic, Rochester, MN, provided management strategies for newly diagnosed multiple myeloma, including the role of autologous stem-cell transplant (ASCT) and posttransplant maintenance therapy.

On November 6, 2017, the FDA approved alectinib (Alecensa; Genentech) for the treatment of patients with ALK mutation–positive, metastatic non–small-cell lung cancer (NSCLC), as detected by an FDA-approved test. On the same day, the FDA also converted alectinib’s initial accelerated approval to a full approval for the treatment of patients with metastatic NSCLC and ALK mutation whose disease progressed with or who were intolerant of crizotinib (Xalkori).

On October 31, 2017, the FDA granted accelerated approval to acalabrutinib (Calquence; AstraZeneca) for the treatment of adults with mantle-cell lymphoma (MCL) who have received at least 1 previous therapy. The FDA granted acalabrutinib priority review and breakthrough therapy and orphan drug designations for this indication.

On September 28, 2017, the FDA approved abemaciclib (Verzenio; Eli Lilly), a cyclin-dependent kinase (CDK)4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, and as monotherapy for HR-positive, HER2-­negative advanced or metastatic breast cancer that progressed after endocrine therapy and previous chemotherapy in the metastatic setting.

On October 18, 2017, the FDA approved axicabtagene ciloleucel (Yescarta; Kite Pharma), a CD19-directed genetically modified CAR T-cell immunotherapy, for the treatment, after ≥2 lines of systemic therapies, of adults with several types of relapsed or refractory large B-cell lymphoma, including (1) diffuse large B-cell lymphoma (DLBCL) not otherwise specified, (2) primary mediastinal large B-cell lymphoma, (3) high-grade B-cell lymphoma, and (4) DLBCL arising from follicular lymphoma.

On September 14, 2017, the FDA granted accelerated approval to copanlisib (Aliqopa; Bayer Healthcare) for the treatment of adults with relapsed follicular lymphoma who have received ≥2 previous systemic therapies. Copanlisib received priority review and an orphan drug designation for this indication.