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).

http://www.targetedonc.com/news/ktec19-submission-to-fda-completed-for-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.

http://www.targetedonc.com/news/denosumab-submitted-for-fda-approval-in-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.

http://www.targetedonc.com/news/odac-meeting-scheduled-by-fda-for-neratinib-in-her2-breast-cancer

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).

http://www.targetedonc.com/news/frontline-atezolizumab-approved-by-fda-for-treatment-of-some-bladder-cancer-patients

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.

http://www.targetedonc.com/news/ctl019-granted-breakthrough-designation-by-fda-for-dlbcl

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).

http://www.targetedonc.com/news/regorafenib-receives-fda-approval-for-liver-cancer

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).

http://www.targetedonc.com/news/lorlatinib-granted-breakthrough-therapy-designation-by-fda-for-nsclc

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.

http://www.targetedonc.com/news/midostaurin-approved-by-fda-for-aml

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).

http://www.targetedonc.com/news/brigatinib-approved-by-fda-for-alkpositive-nsclc