A Look Back at the FDA News from October 2020

During the month of October 2020, the FDA granted 5 new approvals across multiple malignancies. The regulatory body also granted several Priority Review designations to applications for approval, as well as 3 Fast Track designations, 1 Breakthrough Therapy designation, and 3 Fast Track designations.

Other notable FDA news from October 2020 include the issuance of a Complete Response Letter in the hematologic malignancy field and an announcement of new FDA draft guidance in the breast cancer space.

Here is a look back at the FDA happenings from the month of October 2020:

FDA Grants Fast Track Designation to CAR T Therapy for B-Cell Malignancies​

At the start of the month, October 1, 2020, the FDA granted a Fast Track designation to the chimeric antigen receptor T-cell agent, CLBR001 in combination with SWI019 as treatment of patients with B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia

FDA Issues Complete Response Letter to Remestemcel-L for Pediatric Steroid-Refractory Acute GVHD​

On October 2, 2020, the FDA issued a Complete Response Letter to the developer of remestemcel-L (Ryoncil), a potential treatment for pediatric patients with steroid-refractory acute-graft-versus-host disease. The letter requested further clinical evidence.

FDA Approves Frontline Nivolumab/Ipilimumab for Malignant Pleural Mesothelioma​

The FDA also approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) on October 2, 2020, for the frontline treatment of adult patients with unresectable malignant pleural mesothelioma.

FDA Grants Breakthrough Therapy Designation to CD123-Directed Antibody-Drug Conjugate​

On October 5, 2020, the FDA granted a Breakthrough Therapy Designation to the CD123-directed antibody-drug conjugate, IMGN632, as treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasms.

FDA Grants Orphan Drug Designation to Investigational CAR T-Cell Agent in Gastric/GEJ Cancer​

An FDA Orphan Drug Designation was granted to the investigational chimeric antigen receptor T-cell therapy, CT041 on October 5, 2020, for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma.

FDA Recommends Clinical Trials Include Premenopausal Women With Breast Cancer​

On October 7, 2020, the FDA announced draft guidance that encourages the inclusion of premenopausal women with breast cancer in clinical trials, which will help researchers determine the efficacy of a hormonal drug or biological products for this population along with others.

FDA Accepts Investigational New Drug Application for NUV-422 as Treatment of High-Grade Gliomas​

The FDA accepted a submission of an investigational New Drug Application for CDK2/4/6 inhibitor NUV-422 on October 13, 2020, as a treatment option for patients with high-grade gliomas.

FDA Grants Fast Track to Novel Small Molecule for Locally Advanced or Metastatic Solid Tumors​

On October 13, 2020, the FDA also granted a Fast Track designation to the novel agent PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that harbor a P53 Y220C mutation.

Rolling NDA Planned for Pacritinib in Myelofibrosis With Severe Thrombocytopenia​

The developer of pacritinib announced on October 14, 2020, the initiation of a rolling submission of a New Drug Application. The application sought FDA approval for the drug as treatment of patients with myelofibrosis with severe thrombocytopenia defined as having platelet counts less than 50 x 109/L.

FDA Approves Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma​

On October 15, 2020, the FDA granted approval to the immune checkpoint inhibitor pembrolizumab (Keytruda) as treatment of patients with relapsed or refractory classic Hodgkin lymphoma.

FDA Grants Orphan Drug Designation to Novel Monoclonal Antibody in Multiple GI Malignancies​

An Orphan Drug Designation had been granted by the FDA to the CD40 antagonistic monoclonal antibody, APX005M on October 15, 2020, for the treatment esophageal and gastroesophageal junction cancer, as well as for the treatment of patients with pancreatic cancer.

FDA Approves Venetoclax Plus LDAC For Older Patients With Newly Diagnosed AML​

On October 16, 2020, the FDA approved venetoclax in combination with azacitidine (Vidaza), decitabine (Dacogen), or low-dose cytarabine, a regimen known as LDAC, as treatment of adults patients with aged 75 years or older with newly-diagnosed acute myeloid leukemia or who have comorbidities precluding intensive induction chemotherapy.

FDA Grants Priority Review to Nivolumab Plus Cabozantinib in Advanced RCC​

A Priority Review designation was granted by the FDA on October 19, 2020, to the supplemental License Application for nivolumab (Opdivo) in combination with cabozantinib (Cabometyx) for the treatment of patients with advanced renal cell carcinoma.

FDA Grants Priority Review to Osimertinib for Early-Stage EGFR-Mutant NSCLC​

On October 20, 2020, the FDA granted Priority Review to a supplemental New Drug Application for adjuvant osimertinib (Tagrisso) as treatment of patients with stage IB/II/IIIA EGFR-mutant non–small cell lung cancer following a complete tumor resection with curative intent.

FDA Grants Fast Track Designation to Ublituximab Plus Umbralisib in CLL​

A Fast Track designation was granted by the FDA on October 21, 2020, to the combination of ublituximab (TGTX-1101) plus umbralisib (TGR-1202; U2) for the treatment of adult patients with chronic lymphocytic leukemia.

FDA Approves Companion Diagnostic for Identification of NTRK Fusions in Solid Tumors​

On October 23, 2020, the FDA granted approval to the FoundationOne®CDx as a companion diagnostic for the identification of NTRK fusions across all solid tumors for the approved larotrectinib (Vitrakvi) treatment of adult and pediatric patients with solid tumors harboring an NTRK fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to cause severe morbidity, and have no satisfactory alternative treatments or have progressed following prior treatment.

FDA Grants Priority Review to sBLA for Trastuzumab Deruxtecan for HER2+ Metastatic Gastric/GEJ Adenocarcinoma​

The supplemental Biologics License Application for trastuzumab deruxtecan as treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma was granted Priority Review by the FDA on October 28, 2020.

FoundationOne Liquid CDx Granted New and Expanded FDA Indications in Various Solid Tumors​

On October 27, 2020, the FDA has granted approval to the FoundationOne®Liquid CDx as a companion diagnostic indicated for the to identify patients who may derive benefit from treatment with 3 FDA-approved targeted therapies, including alpelisib (Piqray), rucaparib (Rubraca), and alectinib (Alecensa).

FDA Grants Priority Review to Frontline Cemiplimab for PD-L1-High Advanced or Metastatic NSCLC​

A Priority Review designation was granted by the FDA on October 29, 2020, to the supplemental Biologics License Application (sBLA) for cemiplimab-rwlc (Libtayo) and granted it Priority Review for the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) with ≥50% PD-L1 expression.

FDA Grants Orphan Drug Designation to Devimistat for Soft Tissue Sarcoma​

On October 29, 2020, the FDA also granted Orphan Drug designation to CPI-613 (devimistat) for the potential treatment of patients with soft tissue sarcoma.