FDA June 2024: Key Approvals and Designations Propel Oncological Advancements Forward

With numerous advancements, approvals, and the fast-tracking of various treatments, June 2024 proved to be a significant month for the FDA.

Notably, imetelstat (Rytelo) was approved for treating transfusion-dependent anemia in patients with lower-risk myelodysplastic syndrome ineligible for erythropoiesis-stimulating agents (ESAs). A few days later, osimertinib (Tagrisso) received priority review from the FDA for the treatment of patients with unresectable stage III EGFR-mutated non–small cell lung (NSCLC) cancer following chemoradiotherapy. Selpercatinib (Retevmo) was approved for patients with advanced or metastatic RET fusion-positive thyroid cancer needing systemic therapy and refractory to radioactive iodine. Additionally, durvalumab (Imfinzi) given in combination with chemotherapy was approved for mismatch repair deficient endometrial cancer.

Blinatumomab (Blincyto) gained approval from the FDA for the treatment of patients with early-stage CD19-positive acute lymphoblastic leukemia (ALL), epcoritamab (Epkinly) was approved for relapsed/refractory follicular lymphoma, and Tepylute (SH-105) was approved for breast and ovarian adenocarcinoma, offering a new ready-to-dilute formulation.

Additionally, a number of new biologics license applications, priority reviews, and designations also were granted in June, highlighting the FDA’s efforts to push forward innovative therapies for a range of disease states.

Here's a look back on all of the FDA happenings from June 2024.

TLX250-CDx Advances Towards FDA Approval With Completed BLA Submission

On June 2, 2024, the biologics license application submission of TLX250-CDx (Zircaix, 89Zr-DFO-girentuximab) for the FDA was completed.

FDA Fast Tracks Lunresertib/Camonsertib in Platinum-Resistant Ovarian Cancer

On June 4, 2024, the FDA granted fast track designation to lunresertib (RP-6306) with camonsertib (RP-3500) for treating adult patients with platinum-resistant ovarian cancer harboring CCNE1 amplifications, FBXW7 mutations, or PPP2R1A mutations, aiming to expedite the development of this treatment.

FDA Greenlights Phase 2/3 Trial of KPG-121/Abiraterone in mCRPC

A clinical trial to evaluate the combination of a new drug called KPG-121 with abiraterone acetate (Zytiga) for treating metastatic castration-resistant prostate cancer as a first-line therapy was approved by the FDA on June 5, 2024.

FDA to Review IND of PFL-002/VERT-002 in MET-Altered NSCLC

Also on June 5, 2024, an investigational new drug application for PFL-002/VERT-002, targeting solid tumors like NSCLC was submitted to the FDA.

FDA Oks Imetelstat in Lower-Risk MDS With Transfusion-Dependent Anemia

The FDA approved imetelstat on June 6, 2024, for the treatment of patients with transfusion-dependent anemia and lower-risk myelodysplastic syndrome who are ineligible for ESAs.

Osimertinib Wins FDA Priority Review in Stage III EGFR+ NSCLC

The FDA granted priority review to the supplemental new drug application of osimertinib for the treatment of patients with unresectable stage III EGFR-mutated NSCLC following chemoradiotherapy on June 10, 2024.

Cancer cells, 3D illustration: © Dr_Microbe - stock.adobe.com

FDA Clears Phase 1 Study of Lomonitinib for R/R AML Treatment in the US

Also on June 10, 2024, the FDA cleared the investigational new drug application for lomonitinib (ZE46-0134) in FLT3-mutated relapsed/refractory acute myeloid leukemia (AML).

SL-172154 Gains FDA Orphan Drug Designation in Acute Myeloid Leukemia

An orphan drug designation was granted to SL-172154 for treating AML on June 10, 2024.

Selpercatinib Wins FDA Traditional Approval for RET Fusion-Positive Thyroid Cancer

On June 12, 2024, the FDA granted traditional approval to selpercatinib for the treatment of for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory.

Durvalumab Plus Chemotherapy Wins FDA Approval in dMMR Endometrial Cancer

Durvalumab with carboplatin plus paclitaxel followed by single-agent durvalumab was approved by the FDA for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient on June 14, 2024.

FDA Expands Blinatumomab Approval Early-Stage CD19+ B-ALL

Blinatumomab gained approval from the FDA on June 14, 2024, for patients with CD19-positive ALL.

FDA Considers Subcutaneous Amivantamab in EGFR-Mutated NSCLC

On June 17, 2024, the FDA received a biologics license application submission for amivantamab-vmjw (Rybrevant) and recombinant human hyaluronidase for subcutaneous administration.

FDA Approves Pembrolizumab Plus Chemo for Endometrial Cancer

Also on June 17, 2024, pembrolizumab (Keytruda) plus chemotherapy became an approved combination for primary advanced or recurrent endometrial carcinoma, regardless of mismatch repair status.

FDA Clears IND Application of ZW171 in Mesothelin-Expressing Cancers

The FDA cleared the investigational new drug application for ZW171 for mesothelin-expressing cancers, also on June 17, 2024.

Cancer cell or tumor illustration in high detail for medical education or science background, Generative AI: © LAYHONG - stock.adobe.com

SLS009 Scores Rare Pediatric Disease Designation in ALL

The FDA granted SLS009 (formerly GFH009) a rare pediatric disease designation on June 24, 2024, for the treatment of pediatric patients with ALL.

CT-0525 Gains FDA Fast Track Designation in HER2-Overexpressing Solid Tumors

On June 25, 2024, the FDA granted a fast track designation to CT-0525 for treating HER2-overexpressing solid tumors.

FDA Issues CRL to Patritumab Deruxtecan in Advanced EGFR-Mutated NSCLC

On June 26, 2024, the FDA issued a complete response letter for the biologics license application of patritumab deruxtecan (HER3-DXd) for patients with advanced non-small cell lung cancer harboring EGFR mutations.

FDA Approves Epcoritamab in Relapsed/Refractory Follicular Lymphoma

Epcoritamab was approved by the FDA for the treatment of relapsed/refractory follicular lymphoma on June 27, 2024.

FDA Fast Track for TUB-040: ADC Shows Promise in Treating Ovarian Cancer

On June 27, 2024, the FDA granted a fast track designation to TUB-040 for the treatment of platinum-resistant ovarian cancer.

FDA Approves Tepylute in Breast and Ovarian Cancer

The FDA approved Tepylute (SH-105), a ready-to-dilute formulation of an existing treatment for breast and ovarian adenocarcinoma on June 28, 2024.