In April 2023, the FDA granted 3 approvals, including the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer, omidubicel for patients with blood cancers in need of allogeneic hematopoietic stem cell transplant, and polatuzumab vedotin-piiq (Polivy) with rituximab (Rituxan), cyclophosphamide, doxorubicin, and prednisone (R-CHP) for previously untreated diffuse large B-cell lymphoma.

The agency also granted fast track designations to 4 agents, accepted supplemental biologics license applications or biologics license applications of 3 agents, and granted 3 orphan drug designations across various cancer types.

The FDA also placed a partial clinical hold on a phase 1 study evaluating MT-0169 (NCT04017130) t in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma (NHL), as well as on a phase 1 study of FHD-609 (NCT04965753) for patients with synovial sarcoma and/or SMARCB1-deleted tumors.

Additionally, while 1 member from the FDA’s Oncologic Drugs Advisory Committee (ODAC) did not vote, the rest of the members voted in favor of restricting the supplemental new drug application for olaparib (Lynparza) combined with abiraterone (Zytiga) and prednisone or prednisolone for treatment of adult patients with metastatic castration-resistant prostate cancer to patients with BRCA-mutant tumors only.

Here is a look back at all of the FDA happenings from April 2023.

FDA Approves Enfortumab Vedotin/Pembrolizumab Combo for Advanced Urothelial Cancer

On April 3, 2023, the FDA granted approval to the combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.

FDA Accepts sNDAs for Encorafenib and Binimetinib for BRAF V600-Mutated NSCLC

The FDA accepted for review supplemental new drug applications for encorafenib (Braftovi) and binimetinib (Mektovi) for patients with metastatic non–small cell lung cancer that harbors a BRAF V600E mutation, as detected by an FDA-approved test on April 4, 2023.

FDA Grants Fast Track Designation to CB-011 for R/R Multiple Myeloma

The FDA granted a fast track designation to CB-011, a CRISPR-edited allogeneic chimeric antigen receptor T-cell therapy, for the treatment of patients with relapsed/refractory multiple myeloma, on April 4, 2023.

FDA Green Lights Fast Track Designation of SynKIR-110 for Mesothelioma

On April 5, 2023, The FDA granted a fast track designation to the investigational new drug, SynKIR-110, for the treatment of patients with mesothelioma.

FDA Accepts BLA of HLX02 for Patients With HER2-Expressing Cancers

Also on April 5, 2023, the FDA accepted a biologics license application of HLX02 for the adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Halts Phase 1 Study MT-0169 Due to Unacceptable Toxicity

The FDA placed a partial clinical hold on the phase 1 study of MT-0169 (NCT04017130), which is investigating the agent in patients with relapsed or refractory multiple myeloma or non-Hodgkin lymphoma, on April 7, 2023.

FDA Grants Orphan Drug Status to TP-1287 for Ewing Sarcoma

The FDA granted an orphan drug designation for TP-1287, an investigational oral CDK9 inhibitor, on April 10, 2023, for the treatment of patients with Ewing sarcoma.

FDA Grants Orphan Drug Designation to OM-301 for Multiple Myeloma

On April 11, 2023, OM-301 received an orphan drug designation from the FDA for the treatment of patients with multiple myeloma.

FDA Considers Pembrolizumab/Chemotherapy for Approval in Advanced Gastric/GEJ Cancer

The FDA accepted a supplemental biologics license application for pembrolizumab (Keytruda) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma on April 13, 2023.

FDA Requests Additional Study of SGX301 for Early-Stage CTCL in Type A Meeting

During a type a meeting between Soligenix, Inc., and the FDA on April 14, 2023, the contents of a refusal to file letter previously issued by the FDA regarding the new drug application for SGX301 (HyBryte) for use in patients with early-stage cutaneous T-cell lymphoma were discussed.

FDA Accepts sBLA of Ide-cel for Triple-Class Exposed R/R Multiple Myeloma

The FDA accepted a supplemental biologics license application for idecabtagene vicleucel (ide-cel; Abecma) on April 17, 2023, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

FDA Approves Omidubicel for Blood Cancers in Need of Transplant

On April 17, 2023, the FDA granted approval to omidubicel as treatment for patients with blood cancers in need of allogeneic hematopoietic stem cell transplant.

FDA Grants Fast Track Designation to Botensilimab/Balstilimab for MSS/dMMR mCRC Treatment

The FDA has granted a fast track designation to the combination of botensilimab (AGEN1181) and balstilimab (AGEN2034) for the treatment of patients with non-microsatellite instability-high/deficient mismatch repair metastatic colorectal cancer who have no active liver involvement, also on April 17, 2023.

FDA Grants Priority Review to Trifluridine/Tipiracil Plus Bevacizumab in mCRC

On April 18, 2023, the FDA granted priority review to a supplemental new drug application for trifluridine plus tipiracil (TPI; Lonsurf) in combination with bevacizumab (Avastin) for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, an anti-EGFR therapy, or if they are RAS wild-type.

FDA Approves Polatuzumab Vedotin Plus R-CHP for Treatment-Naïve DLBCL

The FDA granted approval to polatuzumab vedotin-piiq (Polivy) in combination with R-CHP on April 19, 2023, for the treatment of patients with previously untreated diffuse large B-cell lymphoma.

FDA Extends Decision Date on Quizartinib for FLT3-ITD-Positive AML

On April 20, 2023, the FDA extended the review period for the new drug application of quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for adult patients with newly diagnosed FLT3-ITD-positive acute myeloid leukemia by 3 months.

FDA Type C Meeting Shows Clinical Activity of Darovasertib/Crizotinib in MUM

During a successful type C meeting with the FDA, interim phase 2 study (NCT03947385) results showed promising safety and efficacy in patients with metastatic uveal melanoma when treated with the combination of darovasertib (IDE196) and crizotinib (Xalkori), on April 23, 2023.

FDA Places Partial Clinical Hold on Study of FHD-609 in Synovial Sarcoma

On April 24, 2023, enrollment in a phase 1 study of FHD-609 (NCT04965753) for patients with synovial sarcoma and/or SMARCB1-deleted tumors was paused due to a grade 4 QTc prolongation event in a patient with synovial sarcoma being treated at the second highest dose level.

FDA Fast Tracks 177Lu-PNT2002 for the Treatment of mCRPC

Also on April 24, 2023, the FDA granted fast track designation to the prostate specific membrane antigen-targeted therapy, ¹⁷⁷Lu-PNT2002, for the treatment of patients with metastatic castration-resistant prostate cancer.

FDA Grants ODD to INB-400 and INB-410 for Newly Diagnosed Glioblastoma

The FDA granted an orphan drug designation to INB-400 and INB-410, for the treatment of a broad range of malignant glioma, including newly diagnosed glioblastoma multiforme on April 25, 2023.

FDA's ODAC Votes Yes to Olaparib Combination Being Restricted to BRCAm mCRPC

On April 28, 2023, The FDA’s ODAC voted 11 to 1 in favor of restricting the supplemental new drug application for olaparib (Lynparza) in combination with abiraterone (Zytiga) and prednisone or prednisolone for treatment of adult patients with metastatic castration-resistant prostate cancer to patients with BRCA-mutant tumors only.