A Look Back at the FDA News from February 2022

During February 2022, the FDA approved pembrolizumab CDx for microsatellite instability high (MSI-H) solid tumors. The FDA’s Oncologic Drug Advisory Committee also voted no to approval of frontline sintilimab/chemotherapy in nonsquamous non-small cell lung cancer. Also, multiple new drug applications as well as a supplemental biologics license applications were submitted.

The agency also granted several fast track designations, orphan drug statuses, and priority reviews across many cancer types including gastrointestinal cancer, breast cancer, multiple myeloma, lymphoma, and more.

A clinical hold was placed on the trial of LB1901 in patients with relapsed or refractory T-cell lymphoma in February, and the FDA investigated a potential link between umbralisib (Ukoniq) and an increased risk of death in patients with lymphomas.

Here's a look back at all the FDA happenings from February 2022.

FDA Approves Updated Label of Axi-Cel Based on ZUMA-1 Findings

On February 1, 2022, the FDA approved a label update for axicabtagene ciloleucel (axi-cel; Yescarta) to include prophylactic corticosteroids use in all approved indications based on the safety management cohort of the ZUMA-1 (NCT02348216) trial.

FDA Grants Orphan Drug Designation to Novel KIT Inhibitor for Advanced GIST

The FDA granted orphan drug designation to the small molecule oral pan-variant KIT inhibitor, THE-630, for the treatment of patients with advanced gastrointestinal stromal tumors on February 2, 2022.

FDA Approval Sought for Rylaze in Adult/Pediatric Acute Lymphoblastic Lymphoma and Lymphoblastic Lymphoma

On February 2, 2022, a supplemental biologics license application was been submitted to the FDA for a Monday/Wednesday/Friday intramuscular dosing schedule of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) for use in combination with a chemotherapy regimen to treat adults patients and pediatric patients 1 month or older with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to E. coli-derived asparaginase.

FDA Investigates Possible Increased Risk of Death Associated With Umbralisib in Lymphoma

Umbralisib (Ukoniq) was potentially linked to an increased risk of death in patients with lymphomas, according to an alert for clinical and patients announced by the FDA on February 3, 2022. The oral inhibitor of PI3K-delta and CK1-epsilon is currently approved for patients with marginal zone lymphoma and follicular lymphoma

FDA Grants Orphan Drug Designation to VCN-01 for Retinoblastoma Treatment

VCN-01, a genetically modified oncolytic adenovirus received orphan drug designation by the FDA for the treatment of patients with retinoblastoma on February 8, 2022.

FDA’s ODAC Votes No to Approval of Frontline Sintilimab/Chemotherapy in Nonsquamous NSCLC

On February 10, 2022, the FDA’s Oncologic Drug Advisory Committee voted 14 to 1 that the FDA should require additional clinical trial(s) demonstrating applicability to patients in the United States (US) and US medical care before making a regulatory decision on the biologics license application for sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with nonsquamous non–small cell lung cancer.

FDA Considers New Drug Application for Poziotinib in HER2 Exon 20-Mutant NSCLC

An application for FDA approval was submitted for poziotinib as a potential treatment for patients with non–small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations on February 11, 2022. The phase 2 ZENITH20 trial evaluated poziotinib in previously treated patients with NSCLC with HER2 exon 20 insertion mutations. The results of the trial were the basis of the NDA acceptance.

FDA Grants Orphan Drug Designation for CT103A in R/R Myeloma

Fully human anti-B-cell maturation antigen chimeric antigen receptor T-cell therapy (CT103A) received orphan drug designation from the FDA on February 13, 2022, for the treatment of relapsed and/or refractory multiple myeloma.

New Drug Application Accepted for Adagrasib In KRAS G12C-Mutation NSCLC

On February 15, 2022, a new drug application for adagrasib (MRTX849) seeking approval for the treatment of patients with non-small cell lung cancer harboring KRAS G12C mutation who have received at least 1 prior therapy was accepted for review by the FDA.

FDA Halts Phase 1 Study of CAR T-Cell Therapy in T-Cell Lymphoma

The FDA placed a clinical hold on the phase 1 clinical trial of LB1901 in patients with relapsed or refractory T-cell lymphoma on February 15, 2022.

FDA Grants Priority Review to Liso-Cel for Adults With Relapsed/Refractory LBCL

On February 17, 2022, the FDA accepted a supplemental biologics license application for lisocabtagene maraleucel (liso-cel; Breyanzi) as a potential treatment option for adult patients with relapsed or refractory large B-cell lymphoma after failure of frontline therapy.

FDA Grants Fast Track Status to IO-202 for Relapsed/Refractory AML

An FDA fast track designation was granted to IO-202 for the treatment of patients with relapsed or refractory acute myeloid leukemia on February 18, 2022.

FDA Grants Fast Track Designation Golidocitinib for R/R PTCL Treatment

The FDA granted fast track designation to the oral, potent JAK1-specific inhibitor, golidocitinib on February 18, 2022 for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

FDA Approves Pembrolizumab CDx for MSI-H Solid Tumors

On February 21, 2022, the FoundationOne CDx was approved by the FDA for use as a companion diagnostic to identify patients with microsatellite instability high solid tumors who may be candidates to receive pembrolizumab (Keytruda) and benefit from it.

FDA Accepts sNDA for Zanubrutinib in Adults With CLL/SLL

The FDA accepted the supplemental new drug application for the Bruton's tyrosine kinase inhibitor zanubrutinib (Brukinsa) as a potential treatment option for adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia on February 23, 2022.

FDA Grants Priority Review to Neoadjuvant Nivolumab Plus Chemotherapy for Resectable NSCLC

On February 28, 2022, the FDA accepted a supplemental biologics license application for nivolumab (Opdivo) in combination with chemotherapy and granted it priority review for the neoadjuvant treatment of patients with resectable non–small cell lung cancer

FDA Indication Sought for Ibrutinib in Pediatric Chronic GVHD

A supplemental new drug application was submitted to the FDA seeking approval for ibrutinib (Imbruvica) for the treatment of pediatric and adolescent patients aged 1 year or older with chronic graft-versus-host disease after failure of 1 or more lines of systemic therapy on February 28, 2022.

FDA Approve Cilta-Cel for Relapsed/Refractory Multiple Myeloma
The FDA granted approval of ciltacabtagene autoleucel (cilta-cel; Carvykti) on February 28, 2022, for the treatment of adults with relapsed or refractory multiple myeloma who have received 4 or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

FDA Approves Pacritinib for Patients with Myelofibrosis and Severe Thrombocytopenia

On February 28, 2022, the FDA approved pacritinib (Vonjo) for the treatment of patients with myelofibrosis and severe thrombocytopenia, defined as a platelet count less than 50x10⁹/L.