Jordyn Sava

TP-1287, an investigational oral phosphate prodrug of the CDK9 inhibitor alvocidib, has been granted an orphan drug designation by the FDA for patients with Ewing sarcoma.

CB-011 has received a fast track designation from the FDA for the treatment of relapsed/refractory multiple myeloma and is being investigated in the ongoing CaMMouflage study.

The phase 3 Karmma-3 trial of ide-cel in patients with triple-class-exposed relapsed/refractory multiple myeloma generated significantly improved progression-free survival and overall response rates vs standard regimens.

A first-in-human study is assessing the safety, efficacy, and pharmacokinetics of DK210 as a monotherapy and in combination with immunotherapy, radiotherapy, or chemotherapy for patients with EGFR-expressing solid tumors.

In the KEYNOTE-045 and KEYNOTE-052 trials, pembrolizumab continued to led to durable responses with no new safety signals after 5 years.

With 1.5 years of follow-up, the confirmed objective response rate was 92.5% among patients who were ROS1 tyrosine kinase inhibitor-naïve and 52.6% in crizotinib-pretreated patients in the phase 2 TRUST-I trial.

Neither the LEAP-003 nor LEAP-017 studies study showed survival benefit with pembrolizumab plus lenvatinib for patients with melanoma or colorectal cancer.

In an interview with Targeted Oncology, Bridget Koontz, MD, discussed burnout and its importance in experts treating patients with cancer.

The investigational new drug, SynKIR-110, has received a fast track designation from the FDA for patients with mesothelioma and is continuing to be evaluated in a phase 1 trial.

Multiple trials and techniques have evaluated treatment with HLX02 compared with trastuzumab. Now, the FDA has accepted the biologics license application HLX02 for patients with HER2-overexpressing metastatic breast cancer, breast cancer, gastric cancer, and gastroesophageal junction adenocarcinoma.

The largest registrational study of immune checkpoint inhibitor therapy in relapsed/refractory extranodal natural killer/T-cell lymphoma showed potent and durable antitumor activity with sugemalimab.

Data from a phase 1/2 study of BDC-1001 alone or with nivolumab supports selection of a recommended phase 2 dose, advancement of further phase 2 studies, and assessment of the agent in combination with pertuzumab.

Results from the phase 2 PHAROS trial of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic non–small cell lung cancer has led the FDA to accept supplemental new drug applications for the agents. Further data will be presented at an upcoming medical meeting.

In an interview with Targeted Oncology, Neal D. Shore, MD, FACS, gave an overview of previous and updated findings from the ARAMIS trial for patients with nonmetastatic castration-resistant prostate cancer.

Data from an analysis of the combined NRG-RTOG 0630/9514 trials show that pathologic complete response can be used as a prognostic factor for clinical outcomes in future research of patients with soft tissue sarcoma.

Enfortumab vedotin plus pembrolizumab is now an FDA approved treatment based on positive phase 1b/2 findings.

The next-generation anthracycline Annamycin has been administered to the first patient with relapsed/refractory acute myeloid leukemia in combination with cytarabine in a phase 1/2 study.

Here is a look back at the FDA happenings from March 2023.

A phase 1/2 trial investigating GRC 54276 for the treatment of patients with advanced solid tumors and lymphomas will begin following the acceptance of an investigational new drug application for the agent.

Based on findings from a phase 1 trial, osemitamab has gained an orphan drug designation from the FDA for the treatment of patients with pancreatic cancer.

The FDA has granted a fast-track designation for RRx-001 and accepted the investigational new drug application for a phase 2b trial of severe oral mucositis in chemotherapy- and radiation-treated patients with head & neck cancer.

In an interview with Targeted Oncology, Craig Sauter, MD, discusses available treatments for patients with central nervous system lymphoma and research that will provide more developments moving forward in this space.

In an interview with Targeted Oncology, Raajit K. Rampal, MD, PhD, discussed the currently approved JAK inhibitors used to treat patients with myelofibrosis, and exciting movements in the field.

A full approval has been granted to pembrolizumab by the FDA for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors.

In an interview, Krisda Chaiyachati, MD, MPH, discussed some of the social determinants of health for patients with cancer and some of the challenges patients undergoing treatment face, including transportation insecurity.

At the Society of Gynecologic Oncology 2023 Annual Meeting, data showed that with a median follow-up of 25.8 months, the proportion of patients on Arm A of the NRG-GY017 trial of patients with cervical cancer with 2-year disease-free survival rate was 79% vs 59% in Arm B.

As of March 28, 2023, the partial clinical hold on the phase 1/2 VELA trial, which is evaluating the selective CDK2 inhibitor BLU-222 for patients with solid tumors, has been lifted. Blueprint Medicines has resumed the re-initiation of patient enrollment.

PT886, a novel bispecific antibody which targets claudin 18.2 and CD47, is currently being evaluated in a phase 1 study for patients with gastric, gastroesophageal junction and pancreatic adenocarcinomas.

With little improvement in survival seen for patients with small cell lung cancer, investigators are now assessing novel agents that are shifting the treatment paradigm of extensive disease-small cell lung cancer.

In an interview with Targeted Oncology, Jennifer Y. Wo, MD, highlighted emerging discussions in the metastatic colorectal cancer space, where targeted therapies play a role, and what the next steps for research include.