The United States Food and Drug Agency (US FDA) is the world’s leading organisation for drug approvals. MediPaper offers you insight in the US FDA approvals for oncology and haematology drugs, as reported by the US FDA – in real time.

Atezolizumab FDA approved for PD-L1 positive unresectable triple-negative breast cancer

On 8 March 2019, the FDA granted accelerated approval to atezolizumab (Tecentriq®, Genentech/Roche) in combination with albumin-bound paclitaxel (nab-paclitaxel) for the treatment of adult unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) patients with programmed death 1 ligand (PD-L1) stained tumour-infiltrating immune cells (IC) of any intensity covering ≥1% of the tumour area, as determined by the VENTANA PD-L1 (SP142) Assay companion diagnostic (CDx).

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.

Trifluridine/tipiracil combination FDA approved for metastatic gastric or GEJ adenocarcinoma

On 22 February 2019, the FDA approved the fixed combination tablets of the nucleoside metabolic inhibitor trifluridine plus the thymidine phosphorylase inhibitor tipiracil (Lonsurf®, Taiho Pharmaceutical) for the treatment of adult metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients pretreated with two or more prior lines of chemotherapy including a fluoropyrimidine, a platinum, and either a taxane or irinotecan plus (when appropriate) HER2/neu-targeted therapy.

Pembrolizumab FDA approved for adjuvant treatment of melanoma

On 15 February 2019, the FDA approved pembrolizumab (Keytruda®, Merck) for the adjuvant treatment of melanoma patients with lymph node involvement following complete resection.

Trastuzumab-biosimilar Ontruzant® FDA approved in several indications

On 18 January 2019, the FDA approved the Herceptin®-biosimilar Ontruzant® (trastuzumab-dttb, Samsung BioEpsis), a HER2/neu receptor antagonist, for patients with HER2-overexpressing (HER2+) breast cancer in the adjuvant and metastatic setting, and in metastatic HER2+ gastric cancer patients. Ontruzant® was approved as biosimilar, not as an interchangeable product.

Cabozantinib FDA approved in HCC patients failing sorafenib

On 14 January 2019, the FDA approved cabozantinib (Cabometyx®, Exelixis) for hepatocellular carcinoma (HCC) patients previously treated with sorafenib.

Keytruda® FDA approved for recurrent and metastatic Merkel cell carcinoma

On 19 December 2018, pembrolizumab (Keytruda®, Merck) received accelerated approval by the FDA for the treatment of recurrent locally advanced or metastatic (R/M) Merkel cell carcinoma (MCC) in adult and paediatric patients.

Calaspargase pegol-mknl (Asparlas®) FDA approved in paediatric and young adult acute lymphoblastic leukaemia (ALL) patients

On 20 December 2018, the FDA approved the asparagine specific enzyme calaspargase pegol-mknl (Asparlas®, Servier) as a component of multi-agent chemotherapeutic regimens for the treatment of paediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukaemia (ALL).

Elzonris™ FDA approved for blastic plasmacytoid dendritic cell neoplasm (BPDCN)

On 21 December 2018, the FDA approved the CD123-directed cytotoxin tagraxofusp-erzs (Elzonris™, Stemline Therapeutics), for the treatment of adult and paediatric patients of 2 years and older with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

Olaparib (Lynparza) FDA approved as maintenance for BRCAm ovarian cancer

On 19 December 2018, the FDA approved olaparib (Lynparza®, AstraZeneca) as a maintenance treatment for adult advanced epithelial ovarian, fallopian tube or primary peritoneal cancer patients who achieving a complete or partial response to first-line platinum-based chemotherapy and who have deleterious germline or somatic BRCA-mutatations (gBRCAm or sBRCAm) by an FDA-aproved test or who are suspected to have deleterious BRCA-mutatations (BRCAm).