A Look Back at the FDA News from December 2021

At the end of 2021, the FDA approved 5 drugs or devices for the treatment of patients with cancer or the detection of mutated disease. In addition, several applications for approval were submitted to the FDA in an effort to advance cancer treatment in the future.

Aside from approvals, 1 application was denied pending more research, and many fast track, orphan drug, breakthrough therapy, and regenerative medicine advanced therapy designations were granted in December 2021.

FDA Approves Subcutaneous Daratumumab Triplet for R/R Multiple Myeloma

At the start of December, the FDA granted approval subcutenous daratumumab (Darzalex) plus hyaluronidase-fihj (Faspro) and carfilzomib (Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

More Research Needed to Support FDA Approval of Plinabulin Plus G-CSF for CIN Prevention

On December 1, the FDA decided not to approve plinabulin with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia until further research is conducted.

FDA Orphan Drug Designation Granted to INBRX-109 for Chondrosarcoma

The FDA has granted an orphan drug designation to INBRX-109 on December 2, 2021, for the treatment of chondrosarcoma.

FDA Grants Priority Review to Luspatercept-aamt for Anemia in Adults With NTD Beta Thalassemia

On December 3, 2021, the FDA accepted and granted priority review to the supplemental biologics license application for luspatercept-aamt (Rebozyi) to treat anemia in adult patients with non-transfusion dependent beta thalassemia.

FDA Approves Rituximab Plus Chemotherapy for Pediatric B-NHL and B-AL

The FDA approved rituximab (Rituxan) in combination with chemotherapy on December 3, 2021, for the treatment of pediatric patients aged 6 months to 18 years with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma, Burkitt lymphoma, Burkitt-like lymphoma, or mature B-cell acute leukemia.

FDA Approves Adjuvant Pembrolizumab for Stage IIB or IIC Melanoma

On December 3, 2021, the FDA granted approval to pembrolizumab (Keytruda) for the adjuvant treatment of both adult and pediatric patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

ST101 Granted FDA Fast Track Designation for Glioblastoma Multiforme

The FDA has granted fast track designation to ST101 on December 6, 2021, a peptide antagonist of C/EBPβ for the treatment of patients with glioblastoma multiforme.

Poziotinib for HER2-Mutated NSCLC New Drug Application Submitted to FDA

A new drug application for poziotinib for the treatment of patients with previously-treated locally advanced or metastatic non–small cell lung cancer with HER2 Exon 20 insertion mutations was submitted to the FDA on December 6, 2021.

FDA Approves Another Amivantamab CDx for Detection of EGFR Exon 20-Positive NSCLC

The FDA granted approval to the Ocomine Dx Target Test on December 9, 2021, as a companion diagnostic to assist with the identification of patients with EGFR exon 20 insertion-positive non–small cell lung cancer who may benefit from treatment with amivantamab-vmjw (Rybrevant).

FT516 Lands RMAT Designation for Relapsed/Refractory DLBCL

On December 13, 2021, the FDA has granted a regenerative medicine advanced therapy designation to FT51 for the treatment of relapsed/refractory diffuse large B-cell lymphoma.

FDA Grants Fast Track Designation to NUV-422 for High-Grade Gliomas

An investigational cyclin-dependent kinase 2/4/6 inhibitor, NUV-422, was granted an FDA fast track designation on December 15, 2021 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme.

FDA Approves Abatacept in aGVHD

On December 15, 2021, the FDA has approved abatacept (Orencia) for the prevention of acute graft versus host disease in patients 2 years of age and older receiving unrelated donor hematopoietic stem cell transplantation.

FDA Orphan Drug Designation Granted to ST101 for Advanced Cutaneous Melanomas

The FDA granted a fast track designation to ST101 on December 15, 2021 for the treatment of advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy.

FDA Grants Orphan Drug Designation to Silmitasertib To Treat Medulloblastoma

On December 16, 2021, silmitasertib (CX-4945), a casein kinase 2 inhibitor, was granted an orphan drug designation by the FDA for the treatment of patients with medulloblastoma.

NDA for the Dovitinib Submitted to FDA for Approval in RCC

A new drug application was submitted to the FDA on December 21, 2021 for dovitinib as a potential option in the third-line treatment of patients with renal cell carcinoma.

Patritumab Deruxtecan Granted FDA Breakthrough Therapy Designation for Metastatic or Locally Advanced EGFR+ NSCLC

On December 23, 2021, the FDA granted breakthrough therapy designation to patritumab deruxtecan for the treatment of patients with metastatic or locally advanced EGFR-mutated non-small cell lung cancer with disease progression on or after treatment with a third-generation tyrosine kinase inhibitor and platinum-based therapies.

FDA Grants Fast Track Designation to CYNK-001 for AML Treatment

The FDA granted fast track designation to CYNK-001 on December 27, 2021, a novel on-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy for the treatment of patients with acute myeloid leukemia.

Teclistamab FDA Approval Sought to Treat Relapsed/Refractory Multiple Myeloma

On December 29, 2021, a biologics license application was submitted to the FDA for teclistamab as treatment of patients with relapsed or refractory multiple myeloma.