Cancer care in 2017: the promise of more cures with the challenges of an unstable health care system

Expanded/additional indications

• Nivolumab (Opdivo, Bristol-Myers Squibb; Sep 22) got accelerated expanded indication approval for treatment of hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
• Pembrolizumab (Keytruda, Merck; Sep 22) got accelerated expanded indication approval for recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express PD-L1 as determined by an FDA-approved test.
• DigniCap Scalp Cooling System (Dignitana Inc; Jul 3) was cleared for expanded use for reducing hair loss during chemotherapy for all solid tumors. Marketing authorization for the cooling cap had been granted in 2015 for patients with breast cancer.
• Olaparib tablets (Lynparza, AstraZeneca; Aug 17) got approval for an expanded indication as maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.
• Ibrutinib (Imbruvica, Pharmacyclics; Aug 2) got expanded indication approval for the treatment of adult patients with chronic graft-versus-host disease (cGVHD) after failure of one or more lines of systemic therapy. It was the first FDA-approved therapy for the treatment of cGVHD. (Ibrutinib was previously approved for chronic lymphocytic leukemia/small lymphocytic lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma with 17p deletion, Waldenström’s macroglobulinemia, marginal zone lymphoma, and mantle cell lymphoma).
• Nivolumab (Aug 2) got an accelerated expanded indication for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability-high (MSI-H) metastatic colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
• Dabrafenib and trametinib (Tafinlar and Mekinist, Novartis; Jun 22) were approved for the expanded indication in combination for patients with metastatic NSCLC with BRAF V600E mutation as detected by an FDA-approved test. The combination demonstrated superior efficacy compared with dabrafenib alone (overall response rate: 61% and 27%, respectively).³²
• Pembrolizumab (May 23) got approved for expanded indication for adult and pediatric patients with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed after treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed after treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
• Pembrolizumab (May 18) got approval for expanded indication for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
• Pembrolizumab (May 10) got accelerated expanded indication for use combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic NSCLC.
• Regorafenib (Stivarga, Bayer; Apr 27) got an additional indication for the treatment of patients with HCC who have been previously treated with sorafenib.
• Palbociclib (Ibrance, Pfizer; Mar 31) got an expanded indication that includes first-line therapy for the treatment of hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.
• Pembrolizumab (Mar 15) got an accelerated additional indication approval for treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or those who have relapsed after three or more previous lines of therapy.
• Lenalidomide (Revlimid, Celgene; Feb 22) got an additional indication as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
• Nivolumab (Feb 2) got an accelerated expanded indication 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.