A Look Back at FDA News from December 2019

In December 2019, the FDA approved 5 new treatments in lung cancer, pancreatic cancer, urothelial carcinoma, breast cancer, and prostate cancer. A tissue complete assay was also approved by the FDA for use in a clinical trial evaluating pembrolizumab (Keytruda).

Here’s a look back on the FDA happenings from the month of December 2019:

Additionally, the United States Senate voted to confirm Stephen M. Hahn, MD, FASTRO, as commissioner of Food and Drugs, Department of Health and Human Services (HHS) during a US Senate floor proceeding held on Thursday, December 12, 2019.

Pembrolizumab Granted Priority Review for Treatment of Patients With NMIBC

On December 2, 2019, the FDA granted priority review to a new supplemental Biologics License Application (sBLA) for pembrolizumab, indicating use as treatment of patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma-in-situ with or without papillary tumors who are either ineligible for cystectomy or have chosen not to undergo the procedure.

FDA Approves Atezolizumab Plus Chemotherapy for Treatment of Patients With mNSCLC

The FDA approved the combination of atezolizumab (Tecentriq) plus carboplatin and nab-paclitaxel (Abraxane) for the treatment of patients with metastatic nonsquamous non—small cell lung cancer (mNSCLC) on December 3, 2019.

FDA Grants Regenerative Medicine Advanced Therapy Designation to ADP-A2M4 for Synovial Sarcoma

On December 4, 2019, the FDA granted a Regenerative Medicine Advanced Therapy designation to ADP-A2M4 (MAGE-A4) for the treatment of patients with synovial sarcoma.

FDA Grants Breakthrough Designation to Abatacept for Prevention of Acute GVHD

Abatacept (Orencia) was granted a Breakthrough Therapy Designation by the FDA on December 4, 2019, for the prevention of moderate to severe acute graft-versus-host disease in hematopoietic stem cell transplants from unrelated donors.

FDA Grants IND Clearance to CAR T-cell Drug ICTCAR014 for R/R Non-Hodgkin Lymphoma

On December 4, 2019, an Investigational New Drug application for chimeric antigen receptor (CAR)-T cell agent, ICTCAR014, was cleared by the FDA for treatment of patients with relapsed/refractory non-Hodgkin lymphoma, including those with PD-L1-positive tumors.

Elio Tissue Complete Assay Approved by FDA for Use in a Pembrolizumab-Based Trial

The FDA granted an Investigational Device Exemption approval to the Personal Genome Diagnostics Inc. (PGDx) elio^TMtissue complete assay for use in a Merck trial evaluating pembrolizumab (Keytruda) combinations in NSCLC on December 4, 2019.

FDA Schedules Hearing to Discuss Olaparib for BRCA-Mutant Metastatic Pancreatic Cancer

The FDA Oncologic Drugs Advisory Committee (ODAC) announced a hearing for December 17, 2019, to discuss a supplemental new drug application for olaparib (Lynparza) tablets for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutant metastatic pancreatic adenocarcinoma who have not progressed on first-line platinum-based chemotherapy.

FDA ODAC Waives Review of Luspatercept in Myelodysplastic Syndromes

The FDA’s ODAC will no longer review the sBLA for luspatercept-aamt (Reblozyl) for use as treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes at the meeting on December 18, 2019, according to a press release on December 6, 2019.

FDA Grants Orphan Drug Designation to Zotiraciclib for Treatment of Glioma

On December 4, 2019, zotiraciclib (TG02) was granted an Orphan Drug Designation by the FDA for the treatment of patients with glioma.

BLA Submitted to FDA for KTE-X19 as Treatment of Relapsed/Refractory MCL

A BLA for the investigational CAR T-cell therapy KTE-X19 has been submitted to the FDA for the treatment of adult patients with relapsed/refractory mantle cell lymphoma on December 11, 2019.

Oncologist Stephen Hahn Voted FDA Commissioner by United States Senate

The United States Senate voted to confirm Stephen M. Hahn, MD, FASTRO, as commissioner of Food and Drugs, Department of HHS during a U.S. Senate floor proceeding held on Thursday, December 12, 2019, according to a press release from the HHS. The vote was 72 to 18.

NDA for Ripretinib Submitted to FDA for Treatment of GIST

On December 16, 2019, a New Drug Application (NDA) for ripretinib (DCC-2618) was submitted to the FDA for the treatment of patients with advanced gastrointestinal stromal tumor who have received a prior treatment of imatinib (Gleevec), sunitinib (Sutent), and regorafenib (Stivarga).

Enzalutamide Granted FDA Approval for Treatment of Patients With mCSPC

Enzalutamide (Xtandi) was approved by the FDA on December 16, 2019, for the treatment of metastatic castration-sensitive prostate cancer. This is the first oral agent to be approved for 3 different types of advanced prostate cancer.

FDA Grants Fast Track Designation to LSD1 Inhibitor SP-2577 for Ewing Sarcoma

On December 16, 2019, SP-2577 (Seclidemstat), a potent reversible LSD1 inhibitor, has been granted Fast Track Designation by the FDA for the treatment of relapsed/refractory patients with Ewing sarcoma.

FDA Grants Fast Track Designation for Tipifarnib In Patients with HNSCC

The FDA granted a Fast Track Designation on December 16, 2019, to tipifarnib, a farnesyl transferase (FTase) inhibitor, for the treatment of patients with HRAS-mutant head and neck squamous cell carcinomas who have previously progressed on platinum therapy.

ODAC Recommends Olaparib as First-Line Maintenance for Germline BRCA-Mutated Pancreatic Cancer

On December 18, 2019, the FDA’s ODAC recommended the PARP inhibitor olaparib in a 7-to-5 vote as first-line maintenance therapy for patients with germline BRCA-mutated metastatic pancreatic cancer whose disease did not progress after first-line treatment with platinum-based chemotherapy.

Tucatinib Granted FDA Breakthrough Designation for Treatment of Metastatic HER2-Positive Breast Cancer

On December 18, 2019, the FDA granted Breakthrough Therapy Designation to the addition of tucatinib to trastuzumab (Herceptin) and capecitabine for the treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases who received prior treatment with trastuzumab, pertuzumab (Perjeta), and T-DM1 (Kadcyla).

FDA Advisory Committee Supports Tazemetostat for Treatment of Epithelioid Sarcoma

The FDA’s ODAC unanimously voted in favor of the benefit-risk profile of tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma who are not eligible for curative intent surgery on December 18, 2019.

FDA Grants Priority Review to Encorafenib Doublet for the Treatment of Advanced BRAF V600E-Mutant mCRC

The FDA accepted a supplemental NDA on December 18, 2019 for the combination of encorafenib (Braftovi) and cetuximab (Erbitux) for the treatment of patients with advanced BRAFV600E-mutant metastatic colorectal cancer following 1 to 2 lines of therapy.

FDA Grants Accelerated Approval to Enfortumab Vedotin for the Treatment of Urothelial Cancers

On December 18, 2019, enfortumab vedotin-ejfv (Padcev) was approved by the FDA for treatment of patients with locally advanced or metastatic urothelial cancers who had prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy regimen.

Regulatory Approval Moves Ahead for Lurbinectedin in SCLC

An NDA was filed on December 19, 2019, for accelerated approval with the FDA for lurbinectedin in patients with small cell lung cancer who have progressed after prior platinum-containing therapy.

FDA Grants Priority Review to UGN-101 for Low-Grade Upper Tract Urothelial Cancer

On December 19, 2019, the FDA has granted a priority review designation to the NDA for UGN-101 (mitomycin gel) for the potential treatment of patients with low-grade upper tract urothelial cancer.

Application for Rituximab Biosimilar Candidate Submitted to FDA

A BLA was submitted on December 19, 2019, to the FDA for ABP 798, a biosimilar candidate for rituximab (Rituxan).

Trastuzumab Deruxtecan Receives Accelerated Approval by FDA for HER2+ Breast Cancer

Fam-trastuzumab deruxtecan-nxki (Enhertu; DS-8201) was granted an accelerated approval by the FDA for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received at least 2 prior lines of anti—HER2-based regimens in the metastatic setting on December 20, 2019.

FDA Approval Sought for Selinexor for Treatment of Patients With Relapsed or Refractory DLBCL

On December 23, 2019, a NDA for selinexor (Xpovio) was submitted to the FDA for the treatment of patients with relapsed or refractory diffuse large b-cell lymphoma who have had at least 2 prior multi-drug therapies and who are ineligible for stem cell transplantation, including chimeric antigen receptor T-cell therapy.

Tucatinib Developer Seeks FDA Approval for the Treatment of HER2-Positive Breast Cancer

A new drug application was submitted to the FDA on December 23, 2019, for tucatinib in combination with trastuzumab (Herceptin) and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, who have received at least 3 prior HER2-directed drugs alone or in combination with other drugs, in the neoadjuvant, adjuvant, or metastatic setting.

Olaparib Gains FDA Approval for Indication in Pancreatic Cancer

On December 30, 2019, the FDA approved olaparib as treatment of adult patients with deleterious or suspected deleterious germline BRCA