A Look Back at FDA News from January 2020

In January 2020, the FDA approved new treatment options in gastrointestinal stromal tumors, bladder cancer, and epithelioid sarcoma. The FDA also granted several Priority Review Designations, orphan drug designations, and a Fast Track designation, as well as a Breakthrough Therapy designation.

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

The FDA also placed a clinical hold on a phase II trial in T-cell lymphomas and cleared 2 treatments in non—small cell lung cancer and advanced solid tumors.

FDA Grants Orphan Drug Designation to CLR 131 for Treatment of Lymphoplasmacytic Lymphoma

On January 6, 2020, CLR 131, a small-molecule, targeted Phospholipid Drug Conjugate, was granted an Orphan Drug Designation by the FDA for the treatment of patients with lymphoplasmacytic lymphoma.

FDA Grants Fast Track Designation to Infigratinib for First-Line Treatment of Cholangiocarcinoma

Infigratinib (BGJ398) was granted a Fast Track Designation by the FDA on January 6, 2020, for the treatment of cholangiocarcinoma in adult patients with first-line advanced or metastatic disease.

Avapritinib Approved by the FDA for Treatment of PDGFRA 18+ GIST

The FDA approved avapritinib (Ayvakit) on January 9, 2020, for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) who harbor platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, includingPDGFRAD842V mutations. This approval makes avapritinib the first precision medicine therapy for a genomically defined population of patients with GIST

FDA Halts Lacutamab Phase II Trial in Advanced T-cell Lymphomas

On January 9, 2020, the phase II TELLOMAK trial, which is evaluating the safety and efficacy of lacutamab (IPH4102) in patients with advanced T-cell lymphomas, was placed on a partial clinical hold by the FDA. The decision was made following discussions regarding Good Manufacturing Practice deficiencies at a subcontractor site that manufacturers the agent in December of 2019.

FDA Approves Pembrolizumab for Treatment of High-Risk NMIBC

Pembrolizumab (Keytruda) was approved by the FDA on January 8, 2020, for the 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 ineligible for or have elected not to undergo cystectomy.

FDA Grants Priority Review to Olaparib Plus Bevacizumab for Frontline Ovarian Cancer

On January 13, 2020, the supplemental New Drug Application for olaparib (Lynparza), a PARP inhibitor, in combination with bevacizumab (Avastin) was granted Priority Review by the FDA as maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy, based on the results from the phase III PAOLA-1 trial.

Umbralisib Developer Seeks FDA Approval In Marginal Zone Lymphoma and Follicular Lymphoma

Jan 16 - A rolling submission of a New Drug Application (NDA) for umbralisib (TGR-1202) was initiated on January 16, 2020, by drug developer, TG Therapeutics, Inc, which is requesting accelerated approval of the agent from the FDA for the treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma.

FDA Priority Review Granted To Nivolumab/Ipilimumab for Treatment of Advanced NSCLC

The FDA granted priority review on January 15, 2020, to the Biologics License Application for nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with noEGFRor ALKgenomic tumor aberrations.

FDA Grants Priority Review for Rucaparib in Advanced Prostate Cancer

The FDA granted priority review status on a supplemental New Drug Application for rucaparib (Rubraca) in advanced prostate cancer on January 15, 2020, seeking approval for rucaparib as monotherapy treatment in patients with aBRCA1/2mutation resulting in recurrent metastatic castrate-resistant prostate cancer.

Olaparib Granted FDA Priority Review for HRR-Mutant mCRPC

The FDA granted a Priority Review on January 20, 2020 to the New Drug Application for olaparib (Lynparza) as treatment for patients with metastatic castration-resistant prostate cancer and deleterious or suspected deleterious germline or somatic homologous recombination repair gene mutations, who have progressed following prior treatment with a new hormonal agent.

FDA Clears IND for BBT-176 in Patients with EGFR-Mutant NSCLC

On January 19, 2020, the Investigational New Drug Application for the novel EGFR tyrosine kinase inhibitor BBT-176 was cleared by the FDA for treatment ofEGFRC797S—mutant non–small cell lung cancer.

FDA Grants Fast Track Designation to Gene Therapy Combination in EGFR-Mutant NSCLC

The FDA granted a Fast Track Designation on January 21, 2020, to the immune-gene therapy Oncoprex in combination with the EGFR inhibitor osimertinib (Tagrisso) for the treatment of patients withEGFR-mutant non—small cell lung cancer who have progressed after treatment with osimertinib alone.

FDA Grants Priority Review to Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

On January 21, 2020, the FDA granted Priority Review to the Biologics License Application for belantamab mafodotin, an anti—B cell maturation antigen monoclonal antibody for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapies included an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

FDA Orphan Drug Designation Granted to Durvalumab and Tremelimumab in HCC

Durvalumab (Imfinzi) and tremelimumab were granted an Orphan Drug Designation on January 20, 2020, for the treatment of hepatocellular carcinoma.

Atezolizumab/Bevacizumab Developers Submit Application to FDA for Unresectable HCC

A supplemental Biologics License Application was submitted to the FDA on January 27, 2020, for the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

FDA Grants Accelerated Approval to Tazemetostat for Patients With Epithelioid Sarcoma

An accelerated approval was granted on January 23, 2020, by the FDA to the methyltransferase inhibitor tazemetostat (Tazverik) for the treatment of metastatic or locally advanced epithelioid sarcoma in adult and adolescent patients ≥16 years who are not eligible for complete resection.

FDA Grants Priority Review to Selpercatinib in RET Fusion+ NSCLC and Thyroid Cancer

On January 29, 2020, the New Drug Application for selpercatinib (LOXO-292) was granted FDA Priority Review for the treatment of patients with advancedRETfusion—positive non–small cell lung cancer, RET-mutant medullary thyroid cancer, andRETfusion—positive thyroid cancer, based on data from the phase I/II LIBRETTO-001 trial, on January 29, 2020.

FDA Grants Breakthrough Therapy Designation to APR-246 Plus Azacytidine for MDS

On January 30, 2020, the combination of APR-246 and azacytidine was granted Breakthrough Therapy Designation by the FDA for the treatment of myelodysplastic syndromes with susceptibleTP53mutations.

         

FDA Clears IND Application for TPST-1495 in Advanced Solid Tumors