Value-Based Cancer Care Issues

October 2018, Vol 9, No 3

FDA Commissioner Outlines New Plan to Increase Biosimilars by “Balancing Innovation and Competition”

Eileen Koutnik-Fotopoulos

Health Policy

FDA Commissioner Scott Gottlieb, MD, discusses the recent release of the FDA’s 11-part action plan to boost biosimilar development, noting that biosimilar competition is “anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the U.S. several years before they’ll be available to patients here.” [ Read More ]

Opdivo plus Yervoy Approved for MSI-H or dMMR Colorectal Cancer

FDA Approvals, News & Updates

On July 10, 2018, the FDA accelerated the approval of the combination of nivolumab and ipilimumab (Opdivo and Yervoy; Bristol-Myers Squibb) for the treatment of patients aged ≥12 years with metastatic c­o­lorectal cancer (CRC) associated with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) that progressed after chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan. [ Read More ]

Kisqali Receives Expanded Indications for HR-Positive, HER2-Negative Advanced or Metastatic Breast Cancer

FDA Approvals, News & Updates

On July 18, 2018, the FDA approved 2 new indications for ribociclib (Kisqali; Novartis) for use as (1) initial endocrine-based therapy, in combination with an aromatase inhibitor (AI), for the treatment of pre- and perimenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer; as well as (2) an initial endocrine-based therapy or after disease progression while receiving endocrine-based therapy, in combination with fulvestrant for postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. [ Read More ]

Two New Therapies Active in NSCLC with EGFR/HER2 Exon 20 Mutations

Phoebe Starr

Emerging Therapies

Toronto, Canada—Researchers are chipping away at the genetic subtypes of non–small-cell lung cancer (NSCLC). At the recent International Association for the Study of Lung Cancer World Conference, attention was focused on new drugs for NSCLC associated with EGFR and HER2 exon 20 insertions or mutations, which account for anywhere from 3% to 7% of all cases of NSCLC. The presence of these genetic alterations is associated with primary resistance to tyrosine kinase inhibitors (TKIs), with response rates below 12%. [ Read More ]

TLR9 Agonist plus Immunotherapy May Overcome Resistance to PD-1 Inhibition

Phoebe Starr

Emerging Therapies

Chicago, IL—A novel approach using the investigational toll-like receptor 9 (TLR9) agonist CMP-001 in combination with pembrolizumab (Keytruda) may have the potential to reverse resistance to anti–PD-1 therapy, according to data from a pre­liminary phase 1b clinical trial. The addition of CMP-001 to pembrolizu­mab was well-tolerated, with encouraging antitumor responses in patients with metastatic melanoma that progressed with or after treatment with a PD-1 inhibitor. [ Read More ]

Sunitinib After Nephrectomy Benefits Some Patients with Advanced Kidney Cancer

In the Literature

Nephrectomy has been the standard of care in metastatic renal-cell carcinoma for 20 years. However, its role in treating patients with advanced disease in the era of targeted therapy has been brought into question. In the CARMENA study, researchers assessed the benefit of initial nephrectomy followed by targeted therapy with sunitinib (Sutent) in patients with metastatic kidney cancer versus the benefits provided by su­nitinib monotherapy. [ Read More ]