July 2024 Brief

The tissue-based companion diagnostic device was approved for the same therapy and indication in August 2023.

The manufacturer has resubmitted an application to the FDA for approval of the drug cosibelimab, which is being investigated for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma.

The FDA has granted fast track designation to 225Ac-FL-020, a promising PSMA-targeting radionuclide drug conjugate for metastatic castration-resistant prostate cancer.

JCXH-211, a first-in-class LNP-encapsulated self-replicating RNA encoding IL-12, demonstrates promising preclinical efficacy and safety for the treatment of patients with advanced solid tumors.

BNT324/DB-1311 gained fast track designation from the FDA in unresectable advanced or metastatic castration-resistant prostate cancer who have progressed after standard treatments.

The FDA has granted fast track designation to ADI-270, an off-the-shelf CD70-targeted gamma delta CAR T-cell therapy, for treating metastatic or advanced clear cell renal cell carcinoma.

The application of remestemcel-L, a potential first-of-its-kind treatment for pediatric patients following stem cell transplants, has been resubmitted for FDA approval after addressing previous concerns.

The completion of the End of Phase 2 meeting for the phase 1B/2 trial of annamycin and cytarabine in acute myeloid leukemia has been announced.

The FDA has received a 505(b)(2) new drug application seeking approval for a lutetium Lu 177 dotatate injection as a potential treatment for SSTR-positive gastroenteropancreatic neuroendocrine tumors.

A fast track designation has been granted to OBX-115, a TIL cell therapy for the potential treatment of patients with advanced melanoma.

The FDA granted a fast track designation to DSP-5336 in relapsed/refractory AML with a KMT2A rearrangement or NPM1 mutation, showing promising results and safety in early trials.

The FDA has received the submission of an investigational new drug application for a phase 1/2 trial evaluating the combination of silmitasertib and chemotherapy in relapsed/refractory solid tumors.

A dendritic cell vaccine called DOC1021 shows early promise in treating pancreatic cancer and has received a fast track designation from the FDA.

Following the report of a serious and unexpected grade 4 adverse effect, a partial clinical hold has been placed on the phase 1 trial evaluating seclidemstat with azacitidine in myelodysplastic syndrome and chronic myelomonocytic leukemia.

The FDA has granted a rare pediatric disease designation to SLS009 for treating pediatric acute myeloid leukemia.

7MW3711, an innovative antibody-drug conjugate targeting B7-H3, has been granted an orphan drug designation by the FDA for treating small cell lung cancer.

The FDA has accepted and granted priority review to tab-cel, a treatment for Epstein Barr virus-positive posttransplant lymphoproliferative disease.

Agenus was advised by the FDA against filing for accelerated approval of botensilimab plus balstilimab for relapsed/refractory microsatellite stable metastatic colorectal cancer without liver metastases.

Clinical development of ZW191 is planned to begin in the second half of 2024.

AIC100 now has a regenerative medicine advanced therapy designation from the FDA for the treatment of recurrent anaplastic thyroid cancer.

The FDA has approved an individual patient investigational new drug application, allowing for a second dose of a novel CAR T-cell therapy for a patient with recurrent ovarian cancer.

The FDA has accepted the resubmitted application of remestemcel-L, a potential first-of-its-kind treatment for pediatric patients following stem cell transplants.

TLX007-CDx, if approved by the FDA, has the potential to become a new PSMA PET imaging agent for prostate cancer.

The FDA has granted a fast track designation to ozuriftamab vedotin for treating recurrent/metastatic head and neck cancer that progressed after prior therapies.

The FDA’s Oncologic Drugs Advisory Committee convened to assess the need for rigorous trial designs evaluating perioperative regimens in resectable non–small cell lung cancer.

The CAR T-cell therapy UCART22 has been granted orphan drug designation and rare pediatric drug designation from the FDA for the treatment of acute lymphoblastic leukemia.

SenoVax, a novel senolytic immunotherapy for NSCLC, has been submitted as an investigational new drug application to the FDA, initiating a clinical trial to test its efficacy.

The FDA approval of Guardant Shield marks the second blood-based diagnostic test for colorectal cancer in those age 45 and older at average risk of the disease.

The FDA granted priority review to asciminib for the treatment of newly diagnosed, Philadelphia chromosome-positive, chronic phase chronic myeloid leukemia.

The FDA has extended the PDUFA target action date for the new drug application of revumenib for adult and pediatric patients with relapsed/refractory KMT2A-rearranged acute leukemia to December 26, 2024.