A Look Back at the FDA News from April 2022

During April 2022, the a 16 to 0 vote from the FDA’s Oncologic Drugs Advisory Committee voted yes to future approvals of PI3 kinase inhibitors (PI3K) and the FDA granted approval to axicabtagene ciloleucel (Axi-cel;Yescarta) for the treatment of patients with large B-cell lymphoma, as well as to a biologics license application for bevacizumab-maly (Alymsys).

Fast track designations were granted for treatments in acute myeloid leukemia, refractory peripheral T-cell lymphoma, cutaneous T-cell lymphoma, metastatic breast cancer, non–small cell lung cancer, unresectable or metastatic gastric cancer, and gastroesophageal junction cancer. Additionally, new drug applications, orphan drug status, and priority reviews were submitted and withdrawn across various cancer types.

While the FDA lifted the partial clinical hold placed on studies of the combination of magrolimab and azacitidine (Vidaza) for patients with myelodysplastic syndrome and acute myeloid leukemia, the FDA halted the phase 1/2 TakeAim Leukemia trial in patients with acute myeloid leukemia in April, 2022.

Here’s a look back at all the FDA happenings from April 2022.

FDA Approves Second-Line Axi-Cel for Adults With LBCL

On April 1, 2022, the FDA granted approval to axicabtagene ciloleucel (axi-cel;Yescarta) for the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.

FDA Receives BLA Resubmission for I-Omburtamab for CNS/Leptomeningeal Metastasis from Neuroblastoma

Also on April 1, 2022, an application for approval was submitted to the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.

FDA Halts Phase 1/2 Study of Emavusertib in Patients With Relapsed/Refractory AML

The phase 1/2 TakeAim Leukemia study exploring emavusertib (CA-4948) in patients with acute myeloid leukemia and myelodysplastic syndrome was halted by the FDA pending more safety and efficacy data on April 4, 2022.

FDA Fast Tracks PRGN-3006 For R/R Acute Myeloid Leukemia Treatment

The FDA also granted fast track designation to PRGN-3006 UltraCAR-T® for the treatment of patients with relapsed or refractory acute myeloid leukemia on April 4, 2022.

FDA Grants Fast Track Designation to DT2216 for R/R PTCL, CTCL Treatment

On April 6, 2022, the FDA granted fast track designation to DT2216 for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma and cutaneous T-cell lymphoma.

FDA Grants Orphan Drug Status to Serplulimab for Small Cell Lung Cancer

The FDA granted orphan drug designation to serplulimab (HLX10) on April 7, 2022, for the treatment of patients with small cell lung cancer.

FDA Allows Magrolimab Studies to Continue in Patients With MDS and AML

On April 12, 2022, the FDA lifted the partial clinical hold placed on studies of magrolimab in combination with azacitidine (Vidaza) allowing for clinical trials including patients with myelodysplastic syndrome and acute myeloid leukemia to continue.

FDA Grants Orphan Drug Status to Toripalimab for Small Cell Lung Cancer

The FDA granted an orphan drug designation to toripalimab, a PD-1 inhibitor, for patients with small cell lung cancer on April 14, 2022.

FDA Grants Fast Track Status to Bria-IMT for Metastatic Breast Cancer

On April 14, 2022, the FDA also granted fast track designation to cell-based immunotherapy Bria-IMT for the treatment of patients with metastatic breast cancer.

FDA Approval Application for U2 Regimen in CLL and SLL Voluntarily Withdrawn

The pending biologics license application/ supplemental new drug application for the combination of ublituximab (TG-1101) and umbralisib (Ukoniq), or U2, for the treatment of adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma was withdrawn on April 18th, 2022.

FDA Approves Another Bevacizumab Biosimilar, Bevacizumab-maly

The FDA granted approval to the biologics license application for bevacizumab-maly on April 19, 2022, making it the third biosimilar of bevacizumab (Avastin) approved in the United States.

FDA Grants Priority Review to Trastuzumab Deruxtecan for HER2+ NSCLC

Also on April 19, 2022, the FDA granted priority review to a supplemental biologics license application for fam-trastuzumab deruxtecan-nxki (Enhertu) as treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have a HER2 mutation and who have received a prior systemic therapy.

FDA’s ODAC Votes Yes to Requiring Randomized Data for Future PI3Ki Approvals in Hematologic Cancers

During the FDA’s Oncologic Drugs Advisory Committee meeting on April 21, 2022, the committee voted 16 to 0 for future approvals of PI3K to be supported by randomized data given observed toxicities in the drug class, research showing a detriment in overall survival, a narrow range between effective, and toxic doses.

FDA Grants Fast Track Status to CMG901 for Unresectable/Metastatic Gastric/GEJ Cancer

On April 22, 2022, the FDA granted fast track designation to single-agent CMG901 for the treatment of patients with unresectable or metastatic gastric and gastroesophageal junction cancer who have relapsed and/or are refractory to approved therapies.

FDA Grants ODD Status to TTI-101 for Hepatocellular Carcinoma

The FDA has granted orphan drug designation to the STA3 inhibitor, TTI-101, for the treatment of hepatocellular carcinoma on April 25, 2022.

FDA Grants Priority Review to Tremelimumab in Unresectable HCC

The FDA also granted priority review to a biologics license application for tremelimumab on April 25, 2022, for the treatment of patients with unresectable hepatocellular carcinoma, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab).

FDA Grants FTD to Ofra-Vec Plus Paclitaxel for Platinum-Resistant Ovarian Cancer

On April 26, the FDA granted fast track designation to ofranergene obadenovec (ofra-vec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer.

FDA Grants Fast Track Designation to ONC-392 for mNSCLC

Also on April 26, 2022, The FDA granted fast track designation to ONC-392, a next-generation anti-CTLA-4 monoclonal antibody, for the treatment of patients with metastatic NSCLC who have had disease progression on prior anti-PD-L1 therapy.

FDA Grants Breakthrough Therapy Designation to T-DXd for HER2-Low Breast Cancer

The FDA granted breakthrough therapy designation to trastuzumab deruxtecan (Enhertu; T-DXd) for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received prior systemic therapy in the metastatic setting or who have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy on April 28, 2022.

FDA Grants Fast Track Designation to Novel PLK4 Inhibitor for R/R AML

The FDA also granted fast track designation to a first-in-class inhibitor of polo-like kinase 4, CFI-400945, on April 27, 2022, for the treatment of adult patients with relapsed or refractory acute myeloid leukemia.

FDA Accepts Resubmitted NDA for Pedmark in Cisplatin-Induced Ototoxicity

On April 28, 2022, The FDA accepted a resubmitted new drug application (NDA) for Pedmark, a sodium thiosulfate formulation, for the prevention of platinum-induced ototoxicity in pediatric patients under the age of 18 with localized, non-metastatic, solid tumors.

FDA Grants Fast Tracks SQZ-PBMC-HPV for HPV16+ Advanced/Metastatic Solid Tumors

Also on April 28, 2022, the FDA granted fast track designation to SQZ-PBMC-HPV for the treatment of patients with HPV16-positive advanced or metastatic solid tumors.