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All Oncology News

The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

The UK’s National Institute for Health and Care Excellence has approved olaparib for the maintenance treatment of adult patients with relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease responded to platinum-based chemotherapy and harbor BRCA1/2 mutations.

The UK National Institute for Health and Care Excellence has approved palbociclib in combination with fulvestrant for the treatment of female patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer who have received prior endocrine therapy.

The FDA has granted a priority review designation to pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.

China’s National Medical Products Administration has granted approval to enzalutamide for the treatment of patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic following progression on androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.

After 3 years of struggling to meet targets for improved care quality and cost efficiency, many of the 175 practices that have remained in the Oncology Care Model of the Centers for Medicare & Medicaid Services have a decision to make: Assume a share of the downside risk for failure to meet financial targets or exit the OCM by December 3.