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Monthly News Roundup - January 2018

Opdivo Gains New Adjuvant Use in Melanoma

Adjuvant therapy can reduce the risk of cancer recurrence follow surgery that removes the tumor and lymph nodes. Bristol-Myers Squibb’s Opdivo (nivolumab) is now the first PD-1 inhibitor approved as adjuvant treatment for any type of cancer. Based on a head-to-head trial, Opdivo significantly improved recurrence-free survival (RFS) versus Yervoy (ipilimumab) in patients with stage IIIB/C or stage IV melanoma after complete surgical resection including lymph nodes. In the CheckMate-238 clinical trial, Opdivo had an 18-month RFS rate of 66.4% compared with 52.7% for Yervoy, with the median RFS not yet reached in either group. The benefit was observed across both BRAF mutant and BRAF wild-type patients.

Lynparza Use Now Includes Breast Cancer with BRCA Mutations

Roughly 5% to 10% of patients with any type of breast cancer have a breast cancer susceptibility gene (BRCA) gene mutation. Non-mutated BRCA genes normally work to repair damaged DNA and prevent tumor development. This month, the U.S. Food and Drug Administration (FDA) expanded the use of AstraZeneca’s Lynparza (olaparib tablets) as the first approved treatment for patients with metastatic breast cancer with a BRCA mutation. Lynparza, also approved to treat BRCA ovarian cancer, is the first PARP inhibitor approved to treat breast cancer. In clinical breast cancer studies, the median progression-free survival for patients taking Lynparza was 7 months compared to 4.2 months for patients using chemotherapy only.

Gilotrif Use Widens in EGFR Mutation-Positive Lung Cancer

Gilotrif (afatinib) now has an added use for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor (EGFR) mutations (L861Q, G719X and S768I) as detected by an FDA-approved test. In the LUX-Lung clinical trial program, Gilotrif was evaluated in NSCLC patients with these EGFR tumor mutations. The analysis showed that Gilotrif was active based on objective response rate, duration of response, disease control, progression-free survival and overall survival. Gilotrif, an oral once-daily tablet from Boehringer Ingelheim, is also FDA-approved to treat advanced squamous cell carcinoma of the lung.

Amgen’s Xgeva Gains Newly Approved FDA Indication

Bone events such as a fracture can complicate therapy for patients with multiple myeloma. Amgen’s Xgeva (denosumab), a RANK ligand (RANKL) inhibitor, is now approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. In studies, the primary endpoint was met, showing non-inferiority of Xgeva to zoledronic acid (not worse) in delaying the time to the first skeletal-related event in patients with multiple myeloma. The median difference in progression-free survival favored Xgeva by 10.7 months. Xgeva is also approved to treat bone giant cell tumor and hypercalcemia of malignancy refractory to bisphosphonate therapy.

Trulance Newly Approved for IBS-Constipation Subtype

It is estimated that irritable bowel syndrome, constipation subtype (IBS-C) occurs in 4 to 5 out of every 100 U.S. adults. Patients with IBS-C experience stomach pain, hard or lumpy stools and changes in stool frequency that can negatively impact quality of life. The FDA has now approved Synergy’s Trulance (plecanatide) 3 mg tablets to treat IBS-C in adults. Trulance, a guanylate cyclase-C agonist, is also approved for the treatment of chronic idiopathic constipation (CIC). Trulance, can be taken once-daily at any time, with or without food. Linzess (linaclotide) is also a guanylate cyclase-C agonist indicated for IBS-C and CIC.

Posted: January 2018