A Look Back at the FDA News from March 2022

During March 2022, the FDA granted approval to therapies for the patients with resectable non-small cell lung cancer (NSCLC), BRCA-mutated, HER2-negative breast cancer, unresectable or metastatic melanoma, microsatellite instability-high and mismatch repair deficient advanced endometrial carcinoma, and metastatic castration-resistant prostate cancer. The FDA also stamped an indication for a companion diagnostic assay to detect BRCA mutations in high-risk early breast cancer.

New drug applications were submitted for treatments in prostate cancer and cholangiocarcinoma and several fast track designations, orphan drug statuses, and priority reviews were also granted by the agency across many cancer types including gastrointestinal cancer, lymphoma, melanoma, multiple myeloma, leukemia, and more.

A clinical hold was placed on the trial of CYAD-101 in patients with metastatic colorectal cancer mCRC in March, as well as the NEON-2 trial for patients with advanced solid tumors. The FDA also announced new guidelines for cancer clinical trials which align with President Biden's 2016 Cancer Moonshot initiative.

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

FDA Places Partial Clinical Hold on Study of CYAD-101 in mCRC

On the first of the month, the FDA placed a partial clinical hold on the phase 1b CYAD-101-002 study (NCT04991948), which was investigating the use of the novel chimeric antigen receptor T-cell agent CYAD-101 in patients with mCRC.

FDA Releases Guidelines for Cancer Clinical Trials, Aligning With Goals of the Biden Administration

Three guidances were finalized and released by the FDA on March 2, 2022, regarding including older adults in cancer clinical trials, conducting first-in-human cancer trials with expansion cohorts, and developing master protocol designs for efficient review of oncology drugs and biologics.

FDA Grants Fast Track Designation to HPN217 for R/R Multiple Myeloma

On March 2, 2022, the FDA granted fast track designation to HPN217, for the treatment of patients with relapsed or refractory multiple myeloma, which is being evaluated in a phase 1/2 clinical trial.

FDA Grants Orphan Drug Designation to TJ-CD4B for Gastric Cancer

TJ-CD4B had been granted orphan drug designation by the FDA for the treatment of patients with gastric cancer, including gastroesophageal junction carcinoma on March 3, 2022.

FDA Postpones Approval Decision on Ublituximab/Umbralisib in CLL/SLL Pending ODAC Meeting

On March 3, 2022, the FDA announced they will make a decision on the approval application for ublituximab/umbralisib in chronic lymphocytic leukemia and small lymphocytic lymphoma in June following an ODAC meeting.

FDA Approves Neoadjuvant Nivolumab/Chemotherapy for Resectable NSCLC

Nivolumab (Opdivo) in combination with platinum-doublet chemotherapy was granted FDA approval as neoadjuvant treatment for adult patients with resectable non-small cell lung cancer on March 4, 2022.

FDA Grants Priority Review to Ivosidenib Plus Azacitidine for IDH1-Mutant AML

The FDA granted priority review to ivosidenib (Tibsovo) tablets on March 7, 2022, as a potential treatment for patients with previously untreated IDH1-mutated acute myeloid leukemia.

FDA Halts NEON-2 Study of Davoceticept/Pembrolizumab in Adults With Advanced Cancers

A partial clinical hold was placed on March 8, 2022, for the NEON-2 trial by the FDA due to a concern with the safety of davoceticept (ALPN-202) used in combination with pembrolizumab to treat patients with advanced solid tumors.

FDA Grants Orphan Drug Status to Epcoritamab for Follicular Lymphoma Treatment

On March 9, 2022, epcoritamab was granted orphan drug designation by the FDA for the treatment of follicular lymphoma and is being studied in a phase 1/2 clinical trial.

FDA Approval Sought for Darolutamide/Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer

A supplemental new drug application seeking FDA approval for darolutamide (Nubeqa) and docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer was submitted on March 9, 2022.

FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma

Fast track designation was granted to 7HP349, in combination with a CTLA-4 inhibitor on March 9, 2022, for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.

FDA Orphan Drug Designation Granted to HT-KIT for Mastocytosis Treatment

On March 11, 2022, orphan drug designation was granted to HT-KIT from the FDA for the treatment of mastocytosis.

FDA Approves Olaparib as Adjuvant Treatment for BRCA-Mutated HER2-Negative Breast Cancer

Also on March 11, 2022, FDA approval was granted to adjuvant olaparib (Lynparza) for the treatment of BRCA-mutated, HER2-negative breast cancer.

FDA Approves Olaparib CDx to Detect BRCA in High-Risk Early Breast Cancer

The FDA approved the BRACAnalysis CDx test on March 14, 2022, for use as a companion diagnostic with adjuvant olaparib to identify patients with germline BRCA-mutated for patients with HER2 negative, high-risk early-stage breast cancer.

Type C Meeting With FDA Requested by Allarity to Discuss Dovitinib in Third-Line RCC

On March 16, 2022, a type C meeting with the FDA requested by Allarity to discuss potential clinical paths to support approval of dovitinib as a potential option in the third-line treatment of patients with renal cell carcinoma.

FDA Approves Companion Diagnostic for EGFR Therapies for Exon 19 Deletions and Exon 21 Alterations in NSCLC

The FDA approved the FoundationOne CDx as a companion diagnostic to identify patients with non–small cell lung cancer with tumors that harbor EGFR exon 19 deletions or exon 21 substitutions, on March 17, 2022.

FDA Grants Orphan Drug Status to TCB-002 for Patients With Acute Myeloid Leukemia

On March 18, 2022, orphan drug designation was granted to TCB-002 for use as a potential therapeutic option in patients with relapsed/refractory acute myeloid leukemia.

FDA Approves Relatlimab Plus Nivolumab for Unresectable or Metastatic Melanoma

The FDA granted approval to the fixed-dose combination of relatlimab plus nivolumab (Opdualag) for the treatment of adult and pediatric patients with unresectable or metastatic melanoma on March 18, 2022.

FDA Issues Draft Guidance on CAR T-Cell Development and Study Design

Also on March 18, 2022, the FDA released a draft of new recommendations for the manufacture, development, and study design of chimeric antigen receptor T cells.

FDA Approves Pembrolizumab for Select Patients With MSI-H/dMMR Advanced Endometrial Carcinoma

Pembrolizumab is now an FDA-approved treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation as of March 21, 2022.

FDA Approves Lu 177 Vipivotide Tetraxetan for Metastatic Castration-Resistant Prostate Cancer

The FDA granted approval on March 23, 2022, to the agent formerly known as 177Lu-PSMA-617 for the treatment of patients with metastatic castration-resistant prostate cancer in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting.

FDA Denies Approval of Sintilimab With Chemotherapy for Nonsquamous NSCLC

On March 24, 2022, the FDA issued a complete response letter denying approval of sintilimab (Tyvyt) injection in combination with pemetrexed and platinum chemotherapy as frontline treatment for patients with nonsquamous non–small cell lung cancer.

FDA Discourages Marketing Authorization for Zandelisib in Patients With FL or MZL

The FDA discouraged marketing authorization for zandelisib (ME-401) on March 25, 2022, based on data from the phase 2 TIDAL study which examined the PI3K inhibitor in subjects with relapsed/refractory follicular lymphoma or marginal zone lymphoma.

FDA Postpones Decision on Luspatercept-aamt for Anemia in Adults With NTD Beta Thalassemia

On March 25, 2022, it was announced that the FDA is no longer conducting a speedy review of the supplemental biologics license application for luspatercept-aamt (Reblozyl) as treatment for anemia in adults with non-transfusion-dependent beta thalassemia.

FDA Approval Sought for Mirvetuximab Soravtansine in FRα-High Platinum-Resistant Ovarian Cancer

An application for approval was submitted to the FDA for mirvetuximab soravtansine (IMGN853) to treat patients with folate receptor alpha-high platinum-resistant ovarian cancer, on March 29, 2022.

FDA Grants Orphan Drug Designation to Veyonda for Patients With Soft Tissue Sarcoma

On March 30, 2022, orphan drug designation was granted to Veyonda as a form of treatment in patients with soft tissue sarcoma.

FDA Grants Priority Review to Futibatinib for FGFR2+ Locally Advanced/Metastatic Cholangiocarcinoma

The FDA accepted a new drug application for futibatinib on March 30, 2022, seeking approval for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene rearrangement, including gene fusions.

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

On March 31, an application for approval was submitted for the second time to the FDA for I-omburtamab for the treatment of pediatric patients with central nervous system or leptomeningeal metastasis from neuroblastoma.