Sara Karlovitch

Tegavivint is being tested in combination with osimertinib in an effort to prolong overall survival and deepen response in EGFR+ NSCLC.

ST101 was granted a fast track designation based on preliminary data of an ongoing phase 1/2 trial.

The FDA has granted approval to abatacept, the first drug for the prevention of graft versus host disease.

Magrolimab will be tested in combination with various antileukemia therapies at multiple disease points, such as the first line and remission stages.

An RMAT designation granted to FT516 is supported by data from a phase 1 trial of FT516 in patients with diffuse large B-cell lymphoma.

In patients with largely resistant CP-CML, ponatinib showed clinical activity when administered at the 45 mg compared with lower doses.

BOVen was found to induce MRD and to have a tolerable safety profile.

A non-chemotherapy–based targeted regimen comprised of tucatinib, palbociclib, and letrozole was found to prolong central nervous system (CNS) progression-free survival (PFS) in patients with hormone receptor–positive, HER2-positive breast cancer.

The application for poziotinib is supported by the phase 2 ZENITH20 trial. The agent showed a promising safety profile and antitumor activity.

In the phase 3 FOCUS study, a positive result for a secondary end point was observed with melphalan hydrochloride for injection in patients with liver-dominant metastatic ocular melanoma.

In an interview with Targeted Oncology, James M. Foran, MD discussed how recent research has caused a paradigm shift in AML, and which ongoing clinical trials have the potential to change treatment in the near future.

The device is meant to not only target metastatic bone lesions, but also promote the growth of healthy bone.

In an interview with Targeted Oncology, lead author Xichun Hu, MD, PhD, discussed A166 and its impact on HER2-positive breast cancer.

Since the start of the Oncology Care Model program in 2016, Florida Cancer Specialists and Research Institute has saved Medicare $140 million.

With an orphan drug designation from the FDA, INBRX-109 may be on track to become the first FDA-approved treatment for chondrosarcoma.

The combination elicited a complete response in patient with cervical cancer and a partial response in a patient with ovarian cancer.

The approval is based on the phase 2 PLEAIDES study, which found the agent had an ORR of 84.8%, with 82.5% of patients still responding after 9 months.

Here is a look back FDA happenings from November 2021.

KB-0742 is currently being evaluated in a phase 1/2 clinical trial. The terminal half-life was found to be 24 hours.

Markus Joerger, MD, discussed the outcomes and prognostic factors of patients with cancer won contract COVID-19 in an interview with Targeted Oncology.

The TROPION-Breast01 study aims to enroll 700 patients to determine the safety and efficacy of datopotamab deruxtecan in patients with HR-positive, HER2-negative breast cancer.

Milademetan, an MDM2-inhibitor, has already shown preliminary antitumor efficacy in solid tumors.

Venetoclax in combination with EPOCH-R is safe and shows preliminary efficacy in patients with aggressive B-cell lymphoma.

The newly accepted FDA approval application for betibeglogene autotemcel is supported by 5 studies of the agent across all ages of patients. Eighty-nine percent of evaluable patients achieved transfusion independence.

FDA approval has been granted to nab-sirolimus for intravenous use as treatment of patients with advanced malignant perivascular epithelioid cell tumors.

In an interview with Targeted Oncology, Eric Jonasch, MD, discussed the impact belzutifan has had on the VHL-assocaited renal cell carcinoma space, along with unmet clinical needs the agent is addressing.

The study is currently recruiting in 5 states and aims to determine if ruxolitinib affects GvHD rates in patients received HSCT for the treatment of myelofibrosis.

Compared with chemotherapy alone combination of sintilimab (Tyvyt) plus a bevacizumab biosimilar injection and chemotherapy significantly improves progression-free survival in EGFR NSCLC.

In an interview with Targeted Oncology, Susan Pandya, MD discussed the impact ivosidenib has had on the cholangiocarcinoma space, along with remaining unmet clinical needs.

Compared with other regiments, patients with CLL who develop Hodgkin lymphoma AVBD may help to improve overall survival in a patient population with a traditionally poor prognosis.