News|Articles|December 1, 2023
A Look Back at the FDA News From November 2023
Author(s)Jordyn Sava
Here is a look back at the FDA happenings from the month of November 2023.
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.
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.
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.
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.
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.
The FDA granted an orphan drug designation to AL102 on November 6, 2023, for the treatment of patients with desmoid tumors.
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.
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.
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.
On November 10, 2023, THIO was granted an orphan drug designation from the FDA for treatment of glioblastoma.
The FDA granted a fast track designation to RZ-001 for the treatment of patients with glioblastoma on November 10, 2023.
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.
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.
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.
On November 15, 2023, an orphan drug designation was granted to SIRPant-M (SI-101) by the FDA for patients with T-cell lymphoma.
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.
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.
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.
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.
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.
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.
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).
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.
Epcoritamab received a breakthrough drug designation from the FDA in relapsed or refractory follicular lymphoma on November 27, 2023.
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.
Also on November 27, 2023, the FDA has granted approval to nirogacestat (Ogsiveo) for the treatment of adult patients with desmoid tumors.
A fast track designation from the FDA was granted to olvimulogene nanivacirepvec (olvi-vec) in platinum-refractory/-resistant ovarian cancer on November 27, 2023.
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.
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.
The FDA has approved an investigational new drug application for a phase 1/2 study of KSQ-001EX, an engineered tumor infiltrating lymphocyte program.
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.
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.
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