A Look Back at FDA News from February 2020

Mar 04, 2020

In February 2020, the FDA gave indications to multiple therapies meant for treatment of solid tumor and hematologic malignancies. FDA action included 10 Priority Reviews, 2 Breakthrough Therapy designations, and 2 Fast Track designations.

In February 2020, the FDA expedited the review of applications and gave indications to multiple therapies for the treatment of solid tumors and hematologic malignancies. FDA action in February included 10 Priority Reviews, 2 Breakthrough Therapy designations, 2 Fast Track designations, among other indications and announcements.

Other notable FDA activity included a Prescription Drug User Fee Act decision date extension in gastrointestinal stromal tumors and a vote from the Oncologic Drugs Advisory Committee on the future of a combination regimen for treatment of patients with non—small cell lung cancer.

Here’s a look back on the FDA happenings from the month of February 2020:

FDA Extends Decision Date on Avapritinib in Fourth-Line GIST by 3 Months

On February 6, 2020, the FDA extended the Prescription Drug User Fee Act date by 3 months for the new drug application of avapritinib from February 14, 2020, to May 14, 2020. The NDA was seeking accelerated approval for the kinase inhibitor for the treatment of adults with fourth-line gastrointestinal stromal tumors.

FDA Grants Priority Review to BLA for KTE-X19 in Relapsed/Refractory MCL

A Biologics License Application for the investigational chimeric antigen receptor T-cell therapy agent, KTE-X19, was accepted by the FDA on February 10, 2020 and granted Priority Review for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

Pemetrexed Injection Granted FDA Approval for Nonsquamous NSCLC and Malignant Pleural Mesothelioma

On February 10, 2020, the FDA granted approval to injectable pemetrexed for the treatment of patients with locally advanced or metastatic nonsquamous non—small cell lung cancer and for those with malignant pleural mesothelioma.

FDA Grants Fast Track Designation to NBTXR3 in Locally Advanced Head and Neck Cancers

An FDA Fast Track Designation was granted to the first-in-class radioenhancer NBTXR3 with or without cetuximab on February 10, 2020, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.

FDA Grants Priority Review to NDA for Capmatinib inMETExon 14+ NSCLC

On February 11, 2020, the FDA granted Priority Review to the New Drug Application for capmatinib, an investigational selective MET inhibitor, which will be used as treatment for first-line and previously treated patients with locally advanced or metastaticMETexon 14 skipping-mutated non—small cell lung cancer.

FDA Approval Sought for Daratumumab Triplet in Relapsed/Refractory Multiple Myeloma

A supplemental Biologics License Application for daratumumab in combination with carfilzomib and dexamethasone was submitted to the FDA on February 11, 2020 for consideration as treatment for relapsed/refractory multiple myeloma.

FDA Grant Priority Review to Liso-cel In Relapsed/Refractory Large B-cell Lymphoma

On February 13, 2020, the FDA granted Priority Review to the Biologics License Application for lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory large B-cell lymphoma, after at least 2 prior therapies.

FDA Grants Priority Review to Ripretinib for Treatment of Advanced GIST

The FDA granted Priority Review to the New Drug Application for ripretinib as treatment of patients with advanced gastrointestinal stromal tumors on February 13, 2020. This potential FDA approval has a Prescription Drug User Fee Act target action date of August 13, 2020.

FDA Grants Priority Review to Tucatinib Plus Trastuzumab/Capecitabine for Treatment of HER2+ Breast Cancer

On February 13, 2020, the FDA granted Priority Review to the New Drug Application for the combination of tucatinib, trastuzumab, and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting.

FDA Grants Priority Review to Tazemetostat in Relapsed/Refractory Follicular Lymphoma

The FDA granted Priority Review to the New Drug Application for tazemetostat on February 14, 2020, as treatment for patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.

FDA to Accelerate the Approval of Lurbinectedin in Small Cell Lung Cancer

On February 17, 2020, the FDA granted Priority Review to the New Drug Application for lurbinectedin, which is being considered for accelerated approval as a treatment of patients with small cell lung cancer who have progressed after prior platinum-containing therapy.

Two FDA Fast Track Designations Granted to ALX148 for HNSCC and Gastric/GEJ Adenocarcinoma

The FDA granted Fast Track Designation to ALX148 on February 18, 2020, for the first-line treatment of patients with head and neck squamous cell carcinoma, and for the second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma.

FDA Grants Priority Review to Atezolizumab As Monotherapy in Advanced NSCLC

On February 19, 2020, the FDA granted Priority Review to the supplemental Biologic License Application for atezolizumab as first-line treatment of patients with advanced non-squamous and squamous non-small cell lung cancer withoutEGFRor ALKmutations with high PD-L1 expression, as determined by PD-L1 biomarker testing.

FDA Grants Breakthrough Therapy Designation to First-Line Enfortumab Vedotin/Pembrolizumab in Bladder Cancer

The FDA granted Breakthrough Therapy Designation to enfortumab vedotin plus pembrolizumab on February 19, 2020, for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

FDA Grants Priority Review for Selinexor in R/R Diffuse Large B-Cell Lymphoma

On February 19, 2020, a Priority Review supplemental New Drug Application for selinexor, a selective inhibitor of nuclear export, has been accepted for filing by the FDA. The application seeks accelerated approval from the agency as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma.

FDA Grants Priority Review to Brigatinib inALK-Positive Metastatic NSCLC

The FDA granted Priority Review to the New Drug Application for brigatinib as first-line treatment for patients withALK-positive metastatic non—small cell lung cancer as detected by an FDA-approved test, on February 24, 2020.

FDA Reviewing Fixed-Dose Subcutaneous Formulation of Pertuzumab/Trastuzumab in HER2+ Breast Cancer

On February 26, 2020, a fixed-dose subcutaneous formulation of pertuzumab and trastuzumab in combination with intravenous chemotherapy was accepted by the FDA for the treatment of eligible patients with HER2-positive breast cancer, which is supported by results of the phase III FeDeriCa study.

FDA Approves Supplemental NDA for Neratinib in Metastatic HER2-Positive Breast Cancer

The FDA approved a supplemental New Drug Application for neratinib in combination with capecitabine, on February 26, 2020, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received 2 or more anti—HER2-based regimens in the metastatic setting.

FDA Advisory Committee Votes in Favor of Ramucirumab/Erlotinib inEGFR+ Metastatic NSCLC

On February 27, 2020, the FDA Oncologic Drugs Advisory Committee agreed that ramucirumab plus erlotinib showed a favorable benefit/risk profile in patients with untreated metastaticEGFR-positive non—small cell lung cancer in the phase III RELAY study. The vote was 6 to 5 in favor of the combination and ODAC has scheduled a hearing to discuss the terms of the Biologic License Application.

FDA Grants Breakthrough Therapy Designation to Debio 1143 In Front-Line Head and Neck Cancer

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