April 2024: FDA's Landmark Month for Cancer Treatment Innovations

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Here are the latest FDA approvals, designations, and decisions from April 2024.

The FDA unleashed a wave of approvals and promising treatments in April 2024. Specifically, the FDA approved a combination therapy with dostarlimab-gxly (Jemperli) in advanced endometrial cancer, tisotumab vedotin-tftv (Tivdak) in recurrent or metastatic cervical cancer, trastuzumab deruxtecan-nxki (T-DXd; Enhertu) in HER2-positive solid tumors, and alectinib (Alecensa) in ALK-positive non-small cell lung cancer (NSCLC).

Nogapendekin alfa inbakicept-pmln (N-803, Anktiva) was approved by the FDA for patients with Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer in situ with or without Ta or T1 disease,lutetium Lu 177 dotatate (177Lu-Dotatate; Lutathera) was approved for treating pediatric patients with gastroenteropancreatic neuroendocrine tumors, and the FDA approved trastuzumab-strf (HLX02), a biosimilar of trastuzumab (Herceptin, Hercessi), for HER2-positive cancers.

The FDA also approved Lumisight (pegulicianine) and the Lumicell Direct Visualization System for highlighting residual cancer during surgery, expanded the approval of idecabtagene vicleucel (ide-cel, Abecma) in multiple myeloma, and approved ciltacabtagene autoleucel (cilta-cel; Carvytki) for patients with relapsed/refractory multiple myeloma who were treated with at least 1 prior line of therapy and are refractory to lenalidomide (Revlimid).

In mid-April, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted to support minimal residual disease as an end point in multiple myeloma trials. The FDA also expedited development of drugs for various cancers through fast track designations and accepted applications for new drugs targeting leukemias and bladder cancers.

Here is a look back at the FDA happenings from the month of April 2024.

FDA Accepts BLA for Dato-DXd in HR+/HER2– Breast Cancer

The FDA accepted the biologics license application for datopotamab deruxtecan (Dato-DXd) for the treatment of patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have received prior systemic therapy on April 2, 2024.

Zanidatamab BLA Submitted to FDA for HER2+ Biliary Tract Cancer

Also on April 2, 2024, the rolling submission of a biologics license application seeking FDA approval for zanidatamab (ZW25) as a treatment for previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer has been completed.

Olaptesed Pegol Wins FDA Fast Track Designation in Brain Cancer

The FDA has granted a fast track designation to olaptesed pegol (NOX-A12) plus bevacizumab (Avastin) and radiotherapy for the treatment of patients with newly diagnosed glioblastoma that is resistant to chemotherapy and where measurable tumor remains after surgery on April 2, 2024.

IND Application Submitted to FDA for SynKIR-310 Trial in R/R B-NHL

On April 3, 2024, an investigational new drug application for the phase 1 trial of SynKIR-310 was submitted to the FDA for the treatment of relapsed/refractory B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

FDA Expands Approval for Ide-Cel in Relapsed/Refractory Multiple Myeloma

The FDA approved ide-cel for the treatment of patients with relapsed or refractory multiple myeloma who have received 2 or more prior lines of therapy on April 5, 2024.

FDA Approves Trastuzumab Deruxtecan in HER2+ Solid Tumors

The FDA granted accelerated approval to T-Dxd on April 5, 2024, for the treatment of patients with inoperable or metastatic tumors that express HER2 who have received prior systemic treatment and have no satisfactory alternative treatment options.

FDA Approves Cilta-Cel for Earlier Lines of R/R Multiple Myeloma

Also on April 5, 2024, the FDA has approved cilta-cel for the treatment of patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of therapy and are refractory to lenalidomide.

FDA Grants Breakthrough Therapy Designation to Sunvozertinib in EGFR Exon20+ NSCLC

On April 7, 2024, sunvozertinib (DZD9008) was granted a breakthrough therapy designation from the FDA as a first-line treatment for a specific type of lung cancer.

FDA Considers SH-201 for Treating Certain Leukemias and Cancers

The FDA accepted the new drug application of SH-201 for review as a potential treatment for certain forms of leukemia and other cancers on April 8, 2024.

FDA Grants Fast Track Designation to PT217 in ES-SCLC

The FDA also granted a fast track designation to PT217 for the treatment of patients with extensive-stage small cell lung cancer on April 8, 2024.

FDA Grants Fast Track Designation to LYT-200 in Head and Neck Cancers

The FDA granted a fast track designation to LYT-200 plus anti-PD-1 therapy on April 11, 2024, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma.

FDA’s ODAC Votes 12 to 0 That MRD Is a Viable End Point in Myeloma Trials

On April 12, 2023, the FDA’s ODAC voted 12 to 0 that evidence supported that minimal residual disease could be used as an accelerated approval end point in clinical trials of multiple myeloma.

FDA Accepts IND for UGN-103 in Low-Grade Intermediate-Risk NMIBC

The FDA accepted the investigational new drug application for UGN-103 for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer on April 15, 2024.

Lumisight, Lumicell DVS Gains FDA Approval to Detect Residual Breast Cancer

A new drug application and premarket approval application for Lumisight and the Lumicell Direct Visualization System was granted approval by the FDA as fluorescence imaging in adult patients with breast cancer on April 18, 2024.

FDA Approves Adjuvant Alectinib in ALK+ NSCLC

Also on April 18, 2024, the FDA granted approval to alectinib as an adjuvant treatment following tumor resection for the treatment of patients with ALK-positive NSCLC whose tumors are at least 4 cm or node positive, as detected by an FDA-approved test.

FDA Calls for Boxed Warnings for CAR T-Cell Immunotherapies

It was announced on April 18, 2024, that the FDA is requiring boxed warnings for T-cell malignancies on approved chimeric antigen receptor T-cell therapies.

FDA Grants Ziftomenib Breakthrough Therapy Designation in NPM1-Mutant AML

The FDA granted a breakthrough therapy designation to ziftomenib on April 22, 2024, for the treatment of patients with relapsed/refractory NPM1-mutant acute myeloid leukemia.

FDA Approves Nogapendekin Alfa Inbakicept for BCG-Unresponsive NMIBC Carcinoma In Situ

On April 22, 2024, the FDA approved nogapendekin alfa for patients with Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder CIS with or without Ta or T1 disease.

FDA Approves 177Lu-Dotatate in Patients 12 and Up for GEP-NETs

The FDA approved 177Lu-Dotatate for the treatment of pediatric patients 12 and older with gastroenteropancreatic neuroendocrine tumors on April 23, 2024.

FDA Grants Accelerated Approval to Tovorafenib in Pediatric Low-Grade Glioma

Also on April 23, 2024, tovorafenib (DAY101) was granted accelerated approval by the FDA for the treatment of relapsed or refractory BRAF-altered pediatric low-grade glioma, the most common brain tumor diagnosed in children.

FDA Accepts sBLA of Dostarlimab/Chemo to Include All Advanced Endometrial Cancer

The FDA accepted the supplemental biologics license application for the combination of dostarlimab with standard-of-care chemotherapy, consisting of carboplatin and paclitaxel, to expand treatment to all adult patients with primary advanced or recurrent endometrial cancer, including those with proficient mismatch repair/microsatellite tumors on April 24, 2024.

FDA Approves HLX02, Biosimilar Trastuzumab, for HER2-Positive Cancers

The FDA granted approval for trastuzumab-strf, a biosimilar of trastuzumab, on April 26, 2024, as an adjuvant treatment for HER2-overexpressing breast cancer, as well as for the treatment of patients with HER2-overexpressing metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Tisotumab Vedotin Gains Full FDA Approval in Advanced Cervical Cancer

On April 29, 2024, the FDA has granted full approval to tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer whose disease has progressed on or after chemotherapy.

New FDA Guidance Looks to Improve Clinical Trial Enrollment and Diversity

The FDA announced new guidance on April 30, 2024, to expand eligibility criteria with the goal of improving participation and diversity in oncology clinical trials. These 3 areas of change include laboratory values, washout periods, and performance status.

FDA Clears IND of PRAME TCR-IL-15 NK Program for R/R Myeloid Malignancies

An investigational new drug application for PRAME TCR/IL-15 NK (SY-307) was cleared by the FDA for the treatment of patients with relapsed/refractory myeloid malignancies on April 30, 2024.

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