Oncology

The drug received accelerated approval in October 2017 as monotherapy for adults with MCL who have received at least one prior treatment. The FDA simultaneously converted the conditional approval to full approval for this indication.

The investigational drug, called PMD-026, is currently in phase 2 clinical trials for the treatment of breast cancer.

The antibody-drug conjugate (ADC), marketed by ADC Therapeutics under the brand name Zynlonta, received accelerated approval in April 2021. Full approval is contingent upon positive results from confirmatory trials.

Gastric cancer, commonly known as stomach cancer, is the fifth most common cancer globally and the fifth leading cause of cancer-related deaths.

The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several months and in early 2025, according to Kaelyn Boss, who gave an oncology drug pipeline talk at the 2024 AMCP Nexus meeting this week.

Time can be especially precious for people with advanced cancer. Researchers and clinicians are beginning to consider “time toxicity” as another aspect of treatment that burdens patients and their loved ones.

Breyanzi is a CAR T-cell therapy now approved for four subtypes of non-Hodgkin lymphoma.

Verastem is studying the combination of avutometinib and defactinib to treat low-grade serous ovarian cancer in patients with KRAS-mutations. The company plans to complete the new drug application in the second half of this year.

Tarlatamab — now with the brand name Imdelltra — is the first approved bispecific antibody for a solid tumor.

Breyanzi is now included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology as a recommendation for third-line therapy for relapsed or refractory follicular lymphoma.

Crenolanib may have advantages over other therapies targeting acute myeloid leukemia with FLT3 gene mutations.

Zenocutuzumab is a new type of bispecific antibody that target both HER2 and HER3 proteins to inhibit NRG1 binding and blocking the mechanism for tumor survival. The FDA’s target date is in December 2024.

Bristol Myers Squibb is seeking approval of the subcutaneous formulation for all previous indications of Opdivo. The FDA has assigned a goal date of Dec. 29, 2024.

Research is highlighting how GLP-1 is expressed in prostate cancer, suggesting that GLP-1 agonists might have a future role in the management of this cancer.

Two new studies look at the financial hardships faced by those with a cancer diagnosis. Authors of both suggest there is a need for improving health insurance coverage.

A phase 3 trials showed Tivdak demonstrated a 30% reduction in the risk of death. The U.S. list price is $6,599 per 40 mg single dose vial.

Ojemda will have a wholesale acquisition cost of $33,916 for a 28 day supply and will be distributed through specialty pharmacies Biologics by McKesson and Onco360.

Lutathera is a radiotherapeutic that is now approved for patients 12 years and older neuroendocrine tumors in the pancreas or gastrointestinal tract.

ImmunityBio’s Anktiva is an antibody cytokine fusion protein approved to treat patients with non-muscle invasive bladder cancer.

The FDA is currently reviewing tarlatamab for small-cell lung cancer with a review date in June and datopotamab deruxtecan for non-small cell lung cancer with a review date in the fourth quarter.

New study finds trial enrollment was highest at NCI-designated cancer centers. Researchers said more needs to be done to enroll patients from community cancer sites.

Between 2011 and 2020, 45.6% of new cancer drugs were approved through the accelerated approval pathway, according to a new report from the American Association of Cancer Research.

Datopotamab deruxtecan, which is being reviewed to treat adults with HR-positive, HER2-negative breast cancer, has an FDA target date in the first quarter of 2025. Datopotamab deruxtecan also is under FDA review for non-small cell lung cancer.

FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.