A look back at all the FDA news that happened in the month of August 2018, including several new approvals, a priority review, breakthrough therapy designations, and more in a variety of cancer types.
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 nonsmall 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:
A breakthrough therapy designation was granted to quizartinib on August 1 as a treatment option for adult patients with relapsed/refractoryFTL3-ITD-positive AML.
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 nonmicrosatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed after 1 or more prior lines of systemic therapy.
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.
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).
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-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.
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.
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.
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.
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.
An sNDA was submitted for a once-weekly dose of carfilzomib in combination with dexamethasone for patients with relapsed/refractory myeloma on August 27.