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A Look Back at FDA News in the Month of April

Published Online:7:41 PM, Tue May 1, 2018
The FDA approved several indications throughout the month of April 2018, including rucaparib (Rubraca) for ovarian cancer, nivolumab (Opdivo) plus ipilimumab (Yervoy) for renal cell carcinoma (RCC), fostamatinib (Tavalisse) for chronic immune thrombocytopenia (ITP), osimertinib (Tagrisso) for EGFR+ non-small cell lung cancer (NSCLC), and dabrafenib (Tafinlar) and trametinib (Mekinist) for melanoma.

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:

Moxetumomab Pasudotox Granted FDA's Priority Review Designation for Hairy Cell Leukemia

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.

Priority Review Granted by FDA to Dacomitinib for Frontline Treatment in NSCLC

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.

Maintenance Rucaparib Approved by FDA for Ovarian Cancer

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.

Duvelisib Granted Priority Review by FDA for CLL and Follicular Lymphoma

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.

FDA Introduces Initiatives to Ease Development of Genetic Tests

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.

Nivolumab/Ipilimumab Approved by FDA for Frontline RCC Treatment

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.

Fostamatinib Approved by FDA for Chronic ITP in the Second-Line Setting

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.

Osimertinib Approved by FDA as First-Line Treatment for Patients with EGFR+ NSCLC

On April 19, osimertinib was approved by the FDA for treatment of patients with NSCLC with tumors harboring EGFR mutations of either exon 19 deletions or exon 21 L858R substitution mutations.

Nivolumab Granted Priority Review by FDA for SCLC

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. 

Selinexor Granted Fast Track Designation by FDA for Penta-Refractory Multiple Myeloma

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.

Enrollment on Tazemetostat Clinical Trials Halted by the FDA

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.

FDA Grants Balixafortide Fast Track Designation for Treatment of Metastatic Breast Cancer Subset

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.

FDA Gives Frontline Pembrolizumab Combo Priority Review for Full Approval in NSCLC

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.

Adjuvant Dabrafenib/Trametinib Granted FDA Approval for BRAF+ Melanoma

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.

Cemiplimab Receives Priority Review from FDA for Patients with CSCC

Cemiplimab was granted priority review on April 30 for the treatment of patients with either metastatic cutaneous squamous cell carcinoma (CSCC) or those with locally advanced CSCC who are not eligible for surgery. The FDA is scheduled to make a decision by October 28, 2018.

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