A Look Back at FDA News in August 2018

In August 2018, the FDA approved several drugs and treatment regimens. There were also a number of breakthrough therapy designations granted this month, as well as a new orphan drug designation. One drug was granted a priority review, while several new drug applications (NDAs) and supplemental biologics license applications (sBLAs) were submitted.

There were 2 approvals this month in lung cancer, including pembrolizumab (Keytruda) in combination with chemotherapy for non—small cell lung cancer (NSCLC) and nivolumab (Opdivo) as a monotherapy for small cell lung cancer (SCLC). The FDA also approved a combination regimen of ibrutinib (Imbruvica) and rituximab (Rituxan) for patients with Waldenström macroglobulinemia. Lenvatinib (Lenvima) was approved for hepatocellular carcinoma (HCC) as a first-line therapy, and mogamulizumab-kpkc (Poteligeo) was approved for treatment of patients with cutaneous T-cell lymphoma (CTCL).

Here’s a look back on the FDA happenings for the month of August 2018:

Quizartinib Granted Breakthrough Therapy Designation by FDA for FLT3-ITD+ AML

A breakthrough therapy designation was granted to quizartinib on August 1 as a treatment option for adult patients with relapsed/refractoryFTL3-ITD-positive AML.

Lenvatinib/Pembrolizumab Receives Breakthrough Therapy Designation from FDA for Endometrial Cancer

On August 1, the combination of lenvatinib plus pembrolizumab was granted a breakthrough therapy designation by the FDA as a treatment for patients with advanced and/or metastatic non—microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after 1 or more prior lines of systemic therapy.

Lurbinectedin Granted Orphan Drug Designation from FDA for SCLC

An orphan drug designation was granted by the FDA for lurbinectedin. PharmaMar, the manufacturer of the drug, made the announcement on August 6. Data from a phase II multicenter basket trial support this treatment option for patients with SCLC.

Novel Triplet Regimen for mCRC Granted Breakthrough Designation by FDA

On August, 7, the FDA granted a breakthrough therapy designation to a triplet regimen for treatment of patients withBRAFV600E-mutant mCRC after 1 or 2 prior lines of therapy in the metastatic setting. This combination regimen includes the BRAF inhibitor encorafenib (Braftovi), the MEK inhibitor binimetinib (Mektovi), and the EGFR inhibitor cetuximab (Erbitux).

FDA New Drug Application Completed for Selinexor in Multiple Myeloma

A rolling submission of an NDA was completed on August 7 for selinexor in patients with penta-refractory multiple myeloma. This application was based on data from the phase IIb STORM trial, part 2.

Mogamulizumab Receives FDA Approval for CTCL

Mogamulizumab-kpkc received an FDA approval for the treatment of patients with CTCL who have had at least 1 prior systemic therapy. This approval was announced on August 8.

Lenvatinib Gains FDA Approval for Frontline HCC

The FDA approved lenvatinib in the frontline setting for patients with unresectable HCC, based on data from the phase III REFLECT trial, on August 16.

Nivolumab Approved by FDA for Small Cell Lung Cancer

Pembrolizumab Plus Chemotherapy Received Full FDA Approval for NSCLC

On August 17, the FDA approved nivolumab for use in patients with SCLC. This monotherapy treatment should follow disease progression after a platinum-based chemotherapy and 1 other previous line of therapy.

Pembrolizumab was approved by the FDA for combination use with standard chemotherapy as treatment for patients with metastatic nonsquamous NSCLC. This approval was announced on August 20.

Elotuzumab Triplet Granted Priority Review by FDA for Myeloma

On August 23, an sBLA was granted priority review by the FDA for elotuzumab in combination with pomalidomide and a low dose of dexamethasone. This treatment is being reviewed for patients with relapsed/refractory multiple myeloma after 2 or more prior lines or therapy, including lenalidomide (Revlimid) and a proteasome inhibitor.

Ibrutinib Plus Rituximab Approved by FDA for Waldenstrom Macroglobulinemia

There was an FDA approval on August 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.

Once-Weekly Carfilzomib Submitted for FDA Approval in Myeloma

An sNDA was submitted for a once-weekly dose of carfilzomib in combination with dexamethasone for patients with relapsed/refractory myeloma on August 27.

Dasatinib Application for Pediatric Ph+ ALL Accepted by FDA