In November 2023, 7 approvals were granted by the FDA across various cancer types, including fruquintinib (HMPL-013) in colorectal cancer, repotrectinib (Augtyro) in ROS1-positive locally advanced or metastatic non–small cell lung cancer, capivasertib (Truqap) with fulvestrant (Faslodex) in HR-positive, HER2-negative, locally advanced or metastatic breast cancer, enzalutamide (Xtandi) in nonmetastatic castration-sensitive prostate cancer, and more.

The FDA also cleared 4 investigational new drug applications, granted 4 orphan drug designations, 4 fast track designations, and 3 supplemental biologics applications, and received 1 biologics license application.

This month, the FDA’s Oncologic Drugs Advisory Committee (ODAC) held a meeting to examine the delayed post-approval confirmatory trials for pralatrexate (Folotyn) and belinostat (Beleodaq) in peripheral T-cell lymphoma. Additionally, they discussed strategies to expedite the completion of post-marketing requirement confirmatory trials for oncologic drugs.

A partial clinical hold was placed on a phase 1 NX-2127-001 study (NCT04830137) evaluating NX-2127 for the treatment of various B-cell malignancies. The existing indication of pembrolizumab (Keytruda) plus trastuzumab (Herceptin) and chemotherapy was restricted in the gastric cancer space. Also, a request to review de novo classification for ProSense under 21 CFR 10.75 was filed to the FDA.

Most recently, the FDA launched an investigation into recent reports of T-cell malignancies in patients who received treatment with chimeric antigen receptor (CAR) T immunotherapies.

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

FDA OKs Pembrolizumab Plus Standard Chemotherapy for Advanced BTC

On November 1, 2023, the FDA granted approval to pembrolizumab (Keytruda) combined with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.

FDA Halts Phase 1 Trial of NX-2127 in Various B-Cell Malignancies

A partial clinical was placed on November 1, 2023, by the FDA on the phase 1 NX-2127-001 study of NX-2127 for the treatment of various B-cell malignancies.

FDA Clears IND of Investigational Immunotherapy for NMIBC Development Program

On November 2, 2023, the FDA granted an investigational new drug application to the immunotherapy ZH9, which will be developed for patients with non-muscle invasive bladder cancer.

FDA Grants ODD to Rhenium Obisbemeda for Breast Cancer and Leptomeningeal Metastases

An orphan drug designation was granted by the FDA to rhenium (186Re) obisbemeda as a potential treatment option for patients with breast cancer and leptomeningeal metastases on November 3, 2023.

FDA Grants Orphan Drug Designation to AL102 in Desmoid Tumors

The FDA granted an orphan drug designation to AL102 on November 6, 2023, for the treatment of patients with desmoid tumors.

FDA Restricts Pembro/Chemo Use for Gastric Cancer

The FDA restricted the existing indication of pembrolizumab (Keytruda) plus trastuzumab (Herceptin) and chemotherapy on November 7, 2023, for first-line treatment of locally advanced unresectable or metastatic HER2-expressing gastric or gastroesophageal junction adenocarcinoma to tumors expressing PD-L1 (combined positive score [CPS] ≥ 1) as determined by an FDA-approved test.

FDA Approves Fruquintinib for Previously Treated Metastatic Colorectal Cancer

On November 8, 2023, the FDA approved fruquintinib (HMPL-013) for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

FDA Accepts sBLA for Liso-Cel in Relapsed or Refractory CLL/SLL

The FDA has accepted the supplemental biologics license application for lisocabtagene maraleucel (liso-cel; Breyanzi) to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.

FDA Grants Orphan Drug Designation to THIO for Glioblastoma

On November 10, 2023, THIO was granted an orphan drug designation from the FDA for treatment of glioblastoma.

RZ-001 Gains FDA Fast Track Designation in Glioblastoma

The FDA granted a fast track designation to RZ-001 for the treatment of patients with glioblastoma on November 10, 2023.

FDA OKs PD-L1 pharmDx for Gastric and GEJ Cancer

The PD-L1 IHC 22C3 pharmDx companion diagnostic tool was FDA-approved on November 14, 2023, to aid in the identification of patients with gastric or gastroesophageal junction adenocarcinoma for whom pembrolizumab (Keytruda) is a suitable treatment.

FDA Fast Tracks SONALA-001 Plus MR-Guided Focused Ultrasound in DIPG

The FDA granted a fast track designation to the development program of SONALA-001 in combination with the INSIGHTEC Exablate 4000 Type-2 Device for the treatment of patients with diffuse intrinsic pontine glioma, also on November 14, 2023.

FDA to Review ProSense De Novo Request in Early-Stage Breast Cancer

A request to review de novo classification for ProSense under 21 CFR 10.75 was filed to the FDA on November 15, 2023, for the treatment of patients with early-stage, low-risk breast cancer.

SIRPant-M Receives FDA Orphan Drug Designation for T-Cell Lymphoma

On November 15, 2023, an orphan drug designation was granted to SIRPant-M (SI-101) by the FDA for patients with T-cell lymphoma.

FDA Approves Repotrectinib in ROS1+ NSCLC

The FDA granted approval to repotrectinib (Augtyro) for the treatment of patients with ROS1-positive locally advanced or metastatic non–small cell lung cancer, also on November 15, 2023.

FDA’s ODAC Confronts Issues With Accelerated Approval Program

On November 16, 2023, the FDA’s ODAC met to discuss delays in post-approval confirmatory trials for pralatrexate (Folotyn) and belinostat (Beleodaq) in peripheral T-cell lymphoma, as well as strategies to promote timely completion of post-marketing requirement confirmatory trials in oncologic drugs.

FDA Approves Pembrolizumab/Chemo for Gastric and GEJ Adenocarcinoma

The FDA approved pembrolizumab (Keytruda) and fluoropyrimidine- and platinum-containing chemotherapy on November 16, 2023, for treatment of patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

FDA Greenlights Capivasertib/Fulvestrant in Breast Cancer With PIK3CA, AKT1, PTEN Alterations

The FDA granted approval to the combination of capivasertib (Truqap) with fulvestrant (Faslodex) for the treatment of adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer that harbors 1 or more PIK3CA, AKT1, or PTEN alterations, as detected by an FDA-approved test, following progression on 1 or more endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy, also on November 16, 2023.

FDA OKs Enzalutamide for Nonmetastatic Castration-Sensitive Prostate Cancer

Enzalutamide (Xtandi) was approved by the FDA on November 17, 2023, for the treatment of patients with nonmetastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis.

FDA to Review sBLA for Amivantamab Plus Chemo in EGFRm Advanced NSCLC

A supplemental biologics license application seeking the approval of amivantamab-vmjw (Rybrevant) combined with chemotherapy consisting of carboplatin and pemetrexed was submitted to the FDA on November 20, 2023, for the treatment of patients with locally advanced or metastatic non–small cell lung cancer with EGFR exon 19 deletions or L858R substitution after disease progression on or after osimertinib.

FDA Oks FoundationOne®CDx for Capivasertib/Fulvestrant in Breast Cancer

On November 20, 2023, the FDA also granted approval to the FoundationOne® CDx as a companion diagnostic to identify patients with advanced HR-positive, HER2-negative advanced breast cancer who may be eligible for treatment with the combination of capivasertib (Truqap) and fulvestrant (Faslodex).

FDA Clears IND for Phase 1B Study of TCB008 in AML

On November 27, 2023, the FDA has cleared the investigational new drug application for the phase 1B ACHIEVE2 study of TCB008 (OmnImmune), an allogeneic unmodified cell therapy consisting of activated and expanded gamma delta T cells, in relapsed/refractory acute myeloid leukemia.

FDA Grants Epcoritamab Breakthrough Drug Designation for FL

Epcoritamab received a breakthrough drug designation from the FDA in relapsed or refractory follicular lymphoma on November 27, 2023.

BLA Seeks Approval of Obe-Cel in B-ALL From the FDA

The FDA received a biologics license application on November 27, 2023, seeking the approval of obecabtagene autoleucel (obe-cel; AUTO1) as a potential therapeutic option in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

FDA Approves Nirogacestat for Patients With Desmoid Tumors

Also on November 27, 2023, the FDA has granted approval to nirogacestat (Ogsiveo) for the treatment of adult patients with desmoid tumors.

FDA Grants FTD to Olvi-Vec in Ovarian Cancer Subgroup

A fast track designation from the FDA was granted to olvimulogene nanivacirepvec (olvi-vec) in platinum-refractory/-resistant ovarian cancer on November 27, 2023.

Zotatifin Triplet Gains FDA Fast Track Status in ER+/HER2- Breast Cancer

On November 28, 2023, the FDA has granted a fast track designation to the combination of zotatifin (eFT226), fulvestrant (Faslodex), and abemaciclib (Verzenio) as a second- or third-line treatment for adult patients with estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer with disease progression following treatment with endocrine therapy and a CDK 4/6 inhibitor.

FDA Clears IND for CT-0525 in Solid Tumors Overexpressing HER2

The FDA cleared the investigational new drug application for CT-0525, an ex vivo gene-modified autologous CAR-monocyte cellular therapy for the treatment of HER2-overexpressing solid tumors on November 28, 2023.

FDA Clears IND for Tumor Infiltrating Lymphocyte Therapy

The FDA has approved an investigational new drug application for a phase 1/2 study of KSQ-001EX, an engineered tumor infiltrating lymphocyte program.

FDA Initiates Investigation of CAR T Immunotherapies

On November 28, 2023, following reports of T-cell malignancies in patients who received B-cell maturation agent- or CD19-directed autologous CAR T-cell immunotherapies, the FDA is investigating the risks.

FDA Grants Priority Review to Enfortumab Vedotin/Pembrolizumab in mUC

The FDA accepted for priority review a supplemental biologics license application (sBLA) for enfortumab vedotin-ejfv (Padcev) with pembrolizumab (Keytruda) in locally advanced or metastatic urothelial cancer on November 30, 2023.