A Look Back at FDA News from September 2018

A look back at all the FDA news that happened in the month of September 2018, including several new approvals, priority reviews, a breakthrough therapy designation, and more, in a variety of cancer types.

Several cancer types saw the approval of new agents in September, including hairy cell leukemia, chronic lymphocytic leukemia, follicular lymphoma, non—small cell lung cancer, and Waldenström macroglobulinemia. Additionally, the FDA granted a priority review designation to pembrolizumab (Keytruda) for the treament of merkel cell carcinoma.

Pembrolizumab Granted Priority Review by FDA for Merkel Cell Carcinoma

Here’s a look back at all the FDA happenings from the month of September 2018:

On September 4, an sBLA for pembrolizumab was granted a priority review for the treatment of pediatric and adult patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The decision was based on findings from KEYNOTE-017, a phase II trial.

LOXO-292 Receives Breakthrough Designation From FDA for NSCLC, MTC

FDA's Decision Delayed on Atezolizumab Approval in Frontline NSCLC

Based on data from the phase I LIBRETTO-001 study, the FDA granted a breakthrough designation to LOXO-292 for the treatment of patients with RET fusion-positive NSCLC orRET-mutant MTC on September 5.

On September 6, the FDA extended the review period for an sBLA seeking the approval of atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), carboplatin, and paclitaxel (ABCP) for the frontline treatment of patients with metastatic nonsquamous NSCLC.

Frontline Pembrolizumab Granted Priority Review by FDA for Lower PD-L1 Cutoff in NSCLC

A priority review designation was granted to an sBLA seeking the approval of pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic nonsquamous or squamous NSCLC with a PD-L1 expression level of ≥1% and no EGFR or ALK genomic tumor aberrations. This designation, based on findings from the phase III KEYNOTE-042 trial, was announced September 12.

Moxetumomab Pasudotox Approved by FDA for Treatment of Hairy Cell Leukemia

On September 13, 2018, the FDA approved moxetumomab pasudotox for the treatment of adult patients with relapsed/refractory hairy cell leukemia who received at least 2 prior lines of therapy including a purine nucleoside analog.

Venetoclax CLL Label Updated by FDA to Include MRD Data

The FDA updated the label for venetoclax as a treatment for patients with CLL to now include minimal residual disease (MRD) data seen in the phase III MURANO trial. This update was announced on September 13.

Erdafitinib Submitted to FDA for Approval in Urothelial Carcinoma

The FDA receieved an NDA for erdafitinib on September 19, seeking the agent's approval as a treatment for patients with locally advanced or metastatic urothelial carcinoma and FGFR genetic alterations whose tumors progressed following chemotherapy.

Partial Clinical Hold on Tazemetostat Trials Lifted by FDA

Duvelisib Granted FDA Approval for CLL and Follicular Lymphoma

The partial clinical hold that the FDA previously placed on the tazemetostat program was lifted on September 24. Enrollment for this clinical trials in patients with various solid tumors and hematologic malignancies has reopened.

On September 24, the FDA approved duvelisib (Copiktra) for treatment of patients with relapsed/refractory chronic lymphocytic leukemia, small lymphocytic leukemia, or relapsed/refractory follicular lymphoma. This approval is based on data from the phase III DUO trial and phase II DYNAMO study.

Frontline Dacomitinib Approved by FDA for EGFR+ NSCLC

The FDA approved dacomitinib for the treatment of patients with metastatic NSCLC with EGFR exon 19 deletion of exon 21 L858R substitution mutations who were previously untreated. This approval on September 28, was based on results from the phase III ARCHER 1050 trial.

Ibrutinib Plus Rituximab Approved by FDA for Waldenstrom Macroglobulinemia

There was an FDA approval on September 27 for ibrutinib in combination with rituximab as a treatment across all lines for patients with Waldenström macroglobulinemia. The approval comes based on results from the phase III iNNOVATE (PCYC-1127) trial and after a priority review was granted in June 2018.

Cemiplimab Approved by FDA for CSCC

On September 28, the FDA approved cemiplimab for treatment of patients with metastatic CSCC or patients with locally advanced CSCC who are not candidates for curative surgery or radiation.