June 2024 Brief

The FDA has cleared a phase 2/3 trial testing KPG-121, a novel drug, combined with abiraterone for first-line treatment of metastatic castration-resistant prostate cancer.

An international, multicenter, first-in-human, phase 1/2 study of PFL-002/VERT-002 plans to enroll patients with NSCLC with MET alterations and expects to begin patient enrollment by the end of 2024.

Pending FDA review, TLX250-CDx awaits consideration following the successful outcomes of the phase 3 ZIRCON trial in clear cell renal cell carcinoma.

The FDA granted fast track status to lunresertib and camonsertib for platinum-resistant ovarian cancer with specific mutations, currently being evaluated for safety and efficacy in the phase 1 MYTHIC trial, with results expected in late 2024.

The FDA approved imetelstat for treating patients with lower-risk myelodysplastic syndromes with transfusion-dependent anemia, regardless of ring sideroblast status.

Mikkael A. Sekeres MD, MS, provides insight on the approval of imetelstat for treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia.

A decision on the supplemental new drug application of osimertinib in this population is expected in the fourth quarter of 2024.

An investigational new drug application for lomonitinib has been cleared by the FDA for FLT3-mutated relapsed/refractory AML treatment, and a phase 1 trial evaluating the agent will begin in the US.

SL-172154 is being studied in a phase 1a/1b study in acute myeloid leukemia and higher-risk myelodysplastic syndrome, as well as other phase 1 studies in platinum-resistant ovarian cancer.

Francis P. Worden, MD, provides a brief overview of the approval of selpercatinib and what it means for patients with RET fusion-positive thyroid cancer.

The FDA has approved a treatment regimen combining durvalumab with carboplatin and paclitaxel, followed by durvalumab monotherapy, for adults with primary advanced or recurrent endometrial cancer that is deficient in mismatch repair.

The FDA has greenlighted blinatumomab for the treatment of patients with CD19-positive, B-cell precursor acute lymphoblastic leukemia following a priority review designation.

A biologics license application for subcutaneous amivantamab combined with recombinant human hyaluronidase has been submitted to the FDA for NSCLC indications.

Pembrolizumab plus standard-of-care chemotherapy improved survival in patients with endometrial cancer vs chemotherapy alone.

ZW171, a bispecific antibody targeting MSLN-expressing cancers, has shown promising preclinical results and plans for further regulatory submissions outside the US in late 2024.

The FDA granted a rare pediatric disease designation to a promising new drug, SLS009, for the treatment of pediatric leukemia.

CT-0525 has received a fast track designation from the FDA for the treatment of solid tumors that overexpress HER2.

This FDA approval marks the first subcutaneous bispecific antibody to be approved in patients with relapsed/refractory follicular lymphoma.

Patritumab deruxtecan has been issued a complete response letter to its biologics license application for the treatment for patients with advanced non-small cell lung cancer with EGFR mutations after prior treatment with 2 or more lines of therapy.

A phase 1/2a study is investigating the novel antibody-drug conjugate for the treatment of ovarian and non–small cell lung cancers.

The FDA approved Tepylute, a ready-to-dilute formulation of an existing treatment for breast and ovarian adenocarcinoma.

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