Top 10 Specialty Cancer Drug Approvals of 2017

Specialty drugs accounted for 71% of the 24 drugs to gain FDA approval in 2016. As the specialty pharmacy space expands, specialty drug approvals will continue to dominate the pharmaceutical landscape.

As the FDA works to bring safe and effective drugs onto the marketplace and into the hands of patients, here are 10 of the most significant medications approved in 2017 for patients with cancer:

1. Kisqali (ribociclib)

Kisqali is a selective cyclin-dependent kinase (CDK) inhibitor designed to slow the progression of cancer by inhibiting CDK4/6 proteins. It was approved in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

2. Zejula (niraparib)

This once-daily maintenance therapy was approved in April for the treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in partial response to platinum-based chemotherapy. It is the first PARP inhibitor that is not limited to women with a BRCA mutation.

3. Bavencio (avelumab)

Bavencio is the first and only FDA-approved anti-PD-L1 immunotherapy for adults and pediatric pateints 12 years and older with metastatic Merkel cell carcinoma (mMCC), including those who have not received prior chemotherapy.

4. Rydapt (midostaurin)

This oral kinase inhibitor was granted approval to treat adults with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation positive in combination with standard cytarabine and daunorubicin chemotherapy. Rydapt is also the first approved treatment for adults with advanced systemic mastocytosis, which includes systemic mastocytosis with associated hematological neoplasm and mast cell leukemia.

5. Imfinzi (durvalumab)

Imfinzi received FDA approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This drug is administered by intravenous infusion every 2 weeks.

6. Alunbrig (Brigatinib)

This oral kinase inhibitor was approved to treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori).

7. Kisqali (ribociclib) and Femara (letrozole) co-pack

The Kisqali Femara Co-Pack is approved to treat postmenopausal patients with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. The pack contains 2 prescriptions—– ribociclib tablets and letrozole tablets­­––and helps prevent patients from paying 2 co-payments.

8. Nerlynx (neratinin)

The FDA approved Nerlynx for the extended adjuvant treatment of patients with early HER2-positive breast cancer. The kinase inhibitor is indicated to follow therapy with trastuzumab (Herceptin).

9. Idhifa (enasidenib)

Idhifa received FDA-approval this month to treat adults with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation. Idhifa is an oral inhibitor designed to target the IDH2 enzyme, and is the first and only approved treatment for patients with this form of disease.

10. Vyxeos

Vyxeos is a fixed-combination drug containing daunorubicin and cytarabine. It is approved to treat adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). It is the first treatment approved for patients with this form of cancer.