A Look Back at FDA News from June 2019

In June 2019, the FDA approved a number of agents many fields, including diffuse large B-cell lymphoma (DLBCL), head and neck squamous cell carcinoma (HNSCC), small cell lung cancer (SCLC), gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and multiple myeloma. The FDA also approved the fifth biosimilar for trastuzumab (Herceptin) and another biosimilar for bevacizumab (Avastin) across several indications.

In addition, the FDA granted a fast track desingatoin, a priority review designation, and lifted a clinical hold, among other FDA news.

Here's a look back on the FDA happenings for the month of June 2019:

FDA Accepts BLA for Luspatercept in MDS and Beta-Thalassemia-Associated Anemias

The FDA accepted a biologics license application on June 4, 2019, for the investigational agent luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes—associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adult patients with beta-thalassemia–associated anemia who require RBC transfusions. In addition, a priority review designation was granted for the beta-thalassemia indication.

FDA Grants Fast Track Designation to Momelotinib for Intermediate/High-Risk Myelofibrosis

On June 5, 2019, the FDA granted a fast track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.

Polatuzumab Vedotin Combo Approved by FDA for R/R DLBCL

Combination polatuzumab vedotin (Polivy) plus bendamustine and rituximab (Rituxan; BR) was granted an accelerated approval from the FDA on June 10, 2019 for the treatment of patients with relapsed/refractory DLBCL.

Upfront Pembrolizumab With or Without Chemo Approved for HNSCC by FDA

On June 11, 2019, the FDA approved pembrolizumab (Keytruda) as monotherapy for newly diagnosed patients with metastatic or unresectable recurrent HNSCC whose tumors express PD-L1 (composite positive score ≥1) and for use in combination with platinum and fluorouracil for this patient population, irrespective of PD-L1 expression.

Fifth Biosimilar for Trastuzumab Approved by FDA

The trastuzumab biosimilar ABP 980 (Kanjinti; trastuzumab-anns), was approved on June 13, 2019 by the FDA for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

Pembrolizumab Approved by FDA for Previously Treated Metastatic SCLC

On June 18, 2019, the FDA granted an accelerated approval to single-agent pembrolizumab for the treatment of patients with metastatic SCLC who have disease progression on or after platinum-based chemotherapy and ≥1 other prior line of therapy.

Complete Response Letter Issued by FDA for Quizartinib NDA in AML

A complete response letter was issued to Daiichi Sankyo from the FDA on June 21, 2019, alerting the company to the reasons why the new drug application for quizartinib as a treatment of adult patients with relapsed/refractory FLT3-ITD—positive acute myeloid leukemia would not be approved.

Partial Clinical Hold Lifted for One Venetoclax Trial in Multiple Myeloma

The FDA lifted a partial clinical hold on June 24, 2019 that was placed on the phase III CANOVA trial investigating the combination of venetoclax (Venclexta) and dexamethasone in comparison with pomalidomide (Pomalyst) and dexamethasone in patients with relapsed or refractory multiple myeloma and a transformation (11;14) abnormality.

Niraparib Granted FDA's Priority Review for Advanced Ovarian Cancer

The FDA granted a priority review on June 24, 2019 to a supplemental biologics license application for niraparib (Zejula) as a treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with ≥3 prior chemotherapy regimens, and who have either a BRCAmutation or have homologous recombination deficiency and progressed >6 months after their last platinum-based regimen.

Prefilled Syringe of Lanreotide Approved for GEP-NETs by FDA

On June 24, 2019, a prefilled syringe of lanreotide (Somatuline Depot) was approved by the FDA to enable healthcare providers to administer the injection easier to adults with unresectable, well or moderately differentiated, locally advanced or metastatic GEP-NETS.

Upfront Daratumumab/Rd Combo Approved by FDA for Transplant-Ineligible Myeloma

Frontline combination daratumumab (Darzalex) plus lenalidomide (Revlimid) and dexamethasone (Rd) was approved by the FDA on June 27, 2019 for the treatment of patients with multiple myeloma who are ineligible for autologous stem cell transplantation.

FDA Approves Bevacizumab Biosimilar Zirabev