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T-DM1 FDA approved for early breast cancer

On the 3rd of May 2019, the FDA approved ado-trastuzumab emtansine (Kadcyla® [T-DM1], Genentech/Roche) as adjuvant therapy for human epidermal growth factor receptor (HER2)-positive early breast cancer (EBC) patients with residual invasive disease after neoadjuvant treatment with a taxane and trastuzumab.

U.S. FDA approved immunecheckpoint inhibitors U.S. FDA approved immunotherapies for cancer U.S. FDA approved immunotherapies for cancer

US FDA approved immune-checkpoint inhibitors updated 09-Mar-2019

Know all the United States Food and Drug Administration (U.S. FDA) approved immune-checkpoint inhibitors. Members of MediPaper can download the free PPT slides summarising the U.S. FDA approved immune-checkpoint inhibitors and other U.S. FDA approved immunotherapies.

Trastuzumab/hyaluronidase-oysk subcutaneous formulation FDA approved for HER2‑overexpressing breast cancer

On 28 February 2019, the FDA approved the subcutaneous formulation trastuzumab/hyaluronidase-oysk (Herceptin Hylecta®, Genentech) for the treatment of human epidermal growth factor receptor 2 (HER2)‑overexpressing breast cancer.

Pertuzumab plus trastuzumab and chemotherapy FDA approved as adjuvant treatment of HER2-positive breast cancer with high recurrence score

On 20 December 2017, the FDA granted regular approval to pertuzumab (Perjeta®, Roche/Genentech) for use with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer and a high recurrence risk.

Mylan biosimilar trastuzumab FDA approved for HER2+ breast or metastatic gastric cancer

On 1 December 2017, the FDA approved Ogivri® (trastuzumab-dkst, Mylan) as a biosimilar to Herceptin® (trastuzumab, Genentech) for the treatment of patients with HER2-overexpressing breast or metastatic gastric or gastroesophageal junction adenocarcinoma.

Abemaciclib in combination with fulvestrant FDA approved for HR+, HER2- advanced or metastatic breast cancer progressing following endocrine therapy

On 28 September 2017, the FDA approved abemaciclib (Verzenio®, Eli Lilly and Company) in combination with fulvestrant for women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

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Pembrolizumab approved for advanced gastric cancer

On September 22, 2017, the FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck) for use in patients with locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for PD-L1 as determined by an FDA-approved companion diagnostic (CDx) and progressing after ≥2 prior systemic therapies, including a fluoropyrimidine– and platinum-containing regimen, and, when appropriate, HER2targeted therapy.