A Look Back at the FDA News From December 2023

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Here is a look back at the FDA happenings from the month of December 2023.

December 2023 was a busy month for the field of oncology as the FDA granted 4 approvals, including pirtobrutinib (Jaypirca) for previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), belzutifan (Welireg) for advanced renal cell carcinoma (RCC), enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for locally advanced or metastatic urothelial cancer, and eflornithine (Iwilfin) to reduce the risk of relapse in patients with high-risk neuroblastoma.

In addition to these approved agents, the FDA cleared 4 investigational new drug applications, granted 2 breakthrough drug designations and 1 fast track designation, and gave 3 drugs priority review across cancer types.

Notably, the FDA also issued a complete response letter to the biologics license application seeking the approval of cosibelimab for patients with metastatic or locally advanced cutaneous squamous cell carcinoma and rejected the new drug application for sotorasib for the treatment of locally advanced or metastatic KRAS G12C-mutated non–small cell lung cancer.

Here is a look back at the FDA happenings from the month of December 2023.

FDA Approves Pirtobrutinib in CLL and SLL

On December 4, 2023, the FDA granted accelerated approval to pirtobrutinib (Jaypirca) for the treatment of patients with previously treated CLL/SLL.

FDA Receives IND for GTB-3650 in CD33+ AML and MDS

An investigational new drug application was submitted to the FDA on December 4, 2023, for the development of GTB-3650 for patients with CD33-positive leukemia, including relapsed/refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

FDA Clears IND for CT071 in RRMM and Primary Plasma Cell Leukemia

The FDA cleared an investigational new drug application for CT071 for the treatment of patients with relapsed/refractory multiple myeloma or primary plasma cell leukemia, also on December 4, 2023.

FDA Grants BTD to TAR-200 in Bladder Cancer Subset

On December 4, 2023, TAR-200 also received a breakthrough drug designation from the FDA for patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) who are not amenable to radical cystectomy.

FDA Grants Priority Review to Nivolumab Plus Chemotherapy in mUC

On December 5, 2023, nivolumab (Opdivo) given in combination with cisplatin-based chemotherapy was granted priority review by the FDA in treatment-naive unresectable or metastatic urothelial carcinoma.

Mirvetuximab sBLA Receives FDA Priority Review in Ovarian Cancer

A supplemental biologics license application for mirvetuximab soravtansine-gynx (Elahere) in FRα-positive, platinum-resistant ovarian cancer was granted priority review by the FDA on December 5, 2023.

FDA Grants 2 Designations to Cretostimogene Grenadenorepvec in NMIBC

A breakthrough therapy designation and fast track designation was granted by the FDA on December 5, 2023, to the oncolytic immunotherapy cretostimogene grenadenorepvec for the treatment of patients with high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without Ta or T1 (papillary) tumors.

FDA Clears IND for VIPER-101 in T-Cell Lymphoma

On December 7, 2023, the FDA cleared the investigational new drug application for VIPER-101 for the treatment of patients with T-cell lymphoma. With this clearance, a first-in-human phase 1 trial will be initiated.

FDA Grants Priority Review to Tarlatamab in Advanced SCLC

The FDA accepted and granted priority review for the biologics license application for tarlatamab (AMG 757) for patients with advanced small cell lung cancer with disease progression on or after platinum-based chemotherapy on December 13, 2023.

FDA Approves Eflornithine to Reduce Risk of Relapse in High-Risk Neuroblastoma

Eflornithine (Iwilfin) was granted FDA approval on December 13, 2023, to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma who have had at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy.

FDA Approves Belzutifan for Adult Patients With Advanced RCC

On December 14, 2023, the FDA also approved belzutifan (Welireg) for the treatment of adult patients with advanced RCC whose disease progressed following PD-1/PD-L1 and VEGF tyrosine kinase inhibitor treatment.

FDA OKs Enfortumab Vedotin/Pembrolizumab Combo for Advanced Urothelial Cancer

The FDA approved 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 on December 15, 2023.

FDA Issues CRL to Cosibelimab in Metastatic or Locally Advanced CSCC

On December 18, 2023, a complete response letter was issued by the FDA to the biologics license application seeking the approval of cosibelimab for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not eligible for curative surgery or radiation.

FDA Clears Investigational New Drug Application of AVS100 in Solid Tumors

The FDA cleared an investigational new drug application for AVS100 on December 18, 2023, as a potential treatment option for locally advanced or metastatic solid tumors.

FDA Clears IND of Padeliporfin VTP in Unresectable PDAC

An investigational new drug application for padeliporfin vascular targeted photodynamic was cleared by the FDA on December 20, 2023, and a phase 1 trial will be initiated to evaluate the agent in patients with unresectable pancreatic ductal adenocarcinoma.

FDA Considers First-Line Amivantamab Plus Lazertinib in EGFR+ NSCLC

On December 21, 2023, the FDA received submissions for a supplemental biologics license application and a new drug application seeking the approval of amivantamab-vmjw (Rybrevant) plus lazertinib (Leclaza) for the first-line treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 19 deletions or L858R substitution mutations, as detected by an FDA-approved test.

FDA Rejects NDA for Sotorasib in KRAS G12C-Mutated NSCLC

The new drug application for sotorasib was rejected by the FDA for the treatment of locally advanced or metastatic KRAS G12C-mutated non–small cell lung cancer that has been treated with at least 1 prior line of therapy on December 26, 2023.

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