Jordyn Sava

Two phase 1/2 trials of IAP0971 and IAE0972 in patients with locally-advanced or metastatic malignant tumors have dosed their first patients.

Orphan drug designation has been granted by the FDA to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors.

In an interview with Targeted Oncology, Anne Wooford, MD, discussed a study of 27 patients with a variety of hematological conditions, unable to find a human leukocyte match donor.

Praluzatamab ravtansine achieved confirmed overall response rate in patients with advanced hormone receptor–positive, HER2-negative breast cancer, meeting the primary end point of the phase 2 CTMX-2009-002 trial.

Findings from part A of the phase 2/3 RINGSIDE trial reveal AL102 to demonstrate favorable safety in patients with desmoid tumors.

In an interview with Targeted Oncology, Sam S. Chang, MD, MBA, discussed the background of N-803 plus BCG in patients with BCG-unresponsive non-muscle invasive bladder cancer and what he expects for the future of this space.

A biologics license application resubmission for toripalimab in combination with gemcitabine and cisplatin and for toripalimab monotherapy has been accepted by the FDA.

The Biden Administration has announced a new model, the Enhancing Oncology Model, aimed at improving cancer care for Medicare and Medicaid patients and lowering health care costs.

Rare pediatric disease designation has been awarded to paxalisib for the treatment of patients with atypical rhabdoid or teratoid tumors in rare and highly-aggressive childhood brain cancer.

A look back at all of the FDA happenings of June 2022.

Duvelisib shows possibility of increased risk of death and serious side effects vs other medicines in patients with leukemia and lymphoma.

PT886 was granted orphan drug designation by the FDA for the treatment of patients with pancreatic cancer.

Botensilimab and balstilimab use in patients with microsatellite stable colorectal cancer showed strong durability and superior efficacy, according to expanded data from the phase 1b C-800 study

A phase 1/1b monotherapy clinical trial of RMC-6236 for the treatment of patients with advanced solid tumors driven by a variety of RAS mutations has dosed its first patient.

In an interview with Targeted Oncology, Charles J. Schneider, MD, FACP, provided an overview of the treatment landscape for anal carcinoma, and ongoing research.

During an interview with Targeted Oncology, Gunther Koehne, MD, PhD, explained the need to get experts together and discuss the increased activity of new developments for hematologic malignancies.

A partial clinical hold has been placed by the FDA on the phase 1/2 NUV-422-02 trial examining NUV-422 in solid tumors, including high grade glioma, hormone receptor–positive advanced breast cancer, and metastatic castration-resistant prostate cancer.

In an interview with Targeted Oncology, Adam Weiner, MD, discussed molecular subtyping for prostate cancer based on basal and luminal cell-of-origin and how such research may impact the future of this space.

The FDA has granted accelerated approval to dabrafenib plus trametinib for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors who harbor a BRAF V600E mutation.

During an interview with Targeted Oncology, Nicholas J. Robert, MD, further discussed the data of the MYLUNG study which he presented in a poster at the 2022 American Society of Clinical Oncology Annual Meeting.

Updated data from the CHiRP study demonstrates clinical potential with the RaDaR minimal residual disease test in patients with high-risk hormone receptor–positive human epidermal growth factor receptor 2-negative breast cancer.

Eric Jonasch, MD, further discussed the 2 posters he presented in regard to belzutifan at 2022 ASCO.

Orphan drug designation has been granted by the FDA to PT217 for patients with small cell lung cancer.

An investigational new drug application has been cleared by the FDA for NXP800 as treatment of various advanced cancers.

In an interview with Targeted Oncology, Erika Hamilton, MD, discussed the key takeaways of the updated safety analysis of the DESTINY-Breast03 trial.

Fast track designation has been granted by the FDA to dianhydrogalactitol for the treatment of patients with newly-diagnosed unmethylated glioblastoma.

Orphan drug designation has been granted to QXL138AM for the treatment of patients with pancreatic cancers.

A manageable side-effect profile, signal of efficacy, and 36% increase in the recommended phase 2 dose (RP2D) was seen with a step-up dosing regimen of tebentafusp in patients with metastatic uveal melanoma.

Enrollment has been completed for the phase 3 PRESERVE 1 trial of trilaciclib in patients with metastatic colorectal cancer receiving chemotherapy.

The FDA has received a new drug application for momelotinib as treatment of patients with myelofibrosis.