A Look Back at FDA News in the Month of April

An overview of FDA news that happened in April.

KTE-C19 Submission to FDA Completed for NHL

A biologics license application (BLA) was submitted to the FDA for axicabtagene ciloleucel (KTE-C19) on March 31 as a potential treatment for transplant ineligible patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).


Denosumab Submitted for FDA Approval in Myeloma

A supplemental biologics license application (sBLA) was submitted to the FDA on April 4 for the use of denosumab (Xgeva) for the prevention of skeletal-related events (SREs) in patients with multiple myeloma.


ODAC Meeting Scheduled by FDA for Neratinib in HER2+ Breast Cancer

On April 16, an Oncologic Drugs Advisory Committee (ODAC) hearing was scheduled by the FDA for May 24, 2017, to discuss a new drug application (NDA) for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology.


Frontline Atezolizumab Approved by FDA for Treatment of Some Bladder Cancer Patients

Atezolizumab (Tecentriq) was granted an accelerated approval by the FDA on April 16 as a frontline treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC).


CTL019 Granted Breakthrough Designation by FDA for DLBCL

Tisagenlecleucel-T (CTL019) was granted a breakthrough therapy designation on by the FDA on April 17 for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) after the failure of at least 2 prior therapies, according to Novartis, the developer of the CAR T-cell therapy.


Regorafenib Receives FDA Approval for Liver Cancer

Regorafenib (Stivarga) was approved by the FDA on April 27 as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who have previously received sorafenib (Nexavar).


Lorlatinib Granted Breakthrough Therapy Designation by FDA for NSCLC

Lorlatinib was granted a breakthrough therapy designation by the FDA on April 27 for use in patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) who have previously received 1 or more ALK inhibitors, according to Pfizer, the company developing the next-generation ALK/ROS1 tyrosine kinase inhibitor (TKI).


Midostaurin Approved by FDA for AML

Midostaurin (Rydapt) was approved by the FDA on April 28 for the treatment of adult patients with newly diagnosed FLT3-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.


Brigatinib Approved by FDA for ALK-Positive NSCLC

On April 28, Brigatinib (Alunbrig) was granted an accelerated approval by the FDA as a treatment for patients with metastatic ALK-positive non—small cell lung cancer (NSCLC) who are resistant to prior crizotinib (Xalkori).