The FDA approved several indications throughout the month of April 2018. A number of drugs were granted priority review and Fast Track designation. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests. Check out our list of all FDA happenings from April 2018.
A number of promising agents were granted priority review and Fast Track designation in the fields of hairy cell leukemia (HCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), follicular lymphoma, small cell lung cancer (SCLC), multiple myeloma, breast cancer, and NSCLC. The FDA also halted all clinical trials using tazemetostat as treatment, and new initiatives were introduced to help ease the development of genetic and genomic-based tests.
Check out our list of all the FDA happenings from April 2018:
On April 3, moxetumomab pasudotox was granted priority review designation by the FDA for adult patients with HCL who had previously received 2 or more lines of therapy. This application was based on results of the phase III 1053 study.
The FDA granted a priority review to the EGFR tyrosine kinase inhibitor (TKI) inhibitor, dacomitinib, on April 4. This drug was submitted for treatment of patients with EGFR-positive locally advanced or metastatic NSCLC. The scheduled decision date is September 2018.
Rucaparib tablets were approved by the FDA on April 6 as a maintenance therapy. This is approved as a treatment for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in either complete or partial response to platinum-based chemotherapy.
On April 9, the FDA granted a priority review to duvelisib for treatment of patients with relapsed/refractory CLL/SLL. An accelerated approval was also granted for the treatment of patients with relapsed/refractory follicular lymphoma.
In order to accelerate the process for submitting investigational cancer drugs and biological products, the FDA introduced new guidelines on April 13 to ease development of genetic and genomic-based tests.
On April 16, the FDA approved the combination nivolumab plus ipilimumab in the frontline setting for patients with advanced RCC at intermediate- and poor-risk. This decision comes based on the data from phase III CheckMate-214 trial.
The FDA approved second-line treatment with fostamatinib, an SYK inhibitor, for patients with chronic ITP following insufficient response to previous therapy. This approval was granted on April 17.
On April 19, osimertinib was approved by the FDA for treatment of patients with NSCLC with tumors harboringEGFRmutations of either exon 19 deletions or exon 21 L858R substitution mutations.
After results of the phase I/II CheckMate-032 trial were released, the FDA granted a priority review on April 18 to nivolumab for patients with small cell lung cancer (SCLC) found with disease progression following at least 2 lines of prior therapy.
Based on results of the phase IIb STORM study, a Fast Track Designation was granted by the FDA on April 19 for selinexor (KPT-330) as treatment of patients with multiple myeloma who have previously received at least 3 therapies.
On April 23, the FDA halted enrollment for any clinical trials using tazemetostat for treatment of patients with solid tumors and hematologic malignancies after a safety update was published on a pediatric patient with advanced poorly differentiated chordoma who had developed a secondary T-cell lymphoma during enrollment of a phase I trial.
The FDA granted a Fast Track designation on April 25 to the combination of balixafortide (POL6326) with eribulin (Halaven) for patients with HER2-negative metastatic breast cancer who have received at least 2 prior chemotherapeutic treatments in the metastatic setting.
On April 30, the FDA granted a priority review to the combination of pembrolizumab (Keytruda) and standard chemotherapy in the frontline for patients with metastatic nonsquamous NSCLC.
Based on findings from the COMBI-AD phase III study, the combination of dabrafenib and trametinib was granted FDA approval on April 30 as treatment in the adjuvant setting following complete resection for patients with BRAF V600E- or V600K-positive stage III melanoma.