Oncology

A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.

An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.

Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.

Imjudo is a monoclonal antibody that targets the activity CTLA-4 that was approved to be used in combination with Imfinzi, a PD-L1 inhibitor, for patients with non-small cell lung cancer.

IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.

In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death

If approved, Aphexdra would be used along with G-CSF treatment for autologous transplantation in patients with multiple myeloma. The Prescription Drug User Fee Act target action date is Sept. 9, 2023.

The new indication expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.

The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.

Cotellic, an oral inhibitor of MEK1 and MEK2, was approved to treat patients with histiocytic neoplasms based on a phase 2 trial conducted solely at Memorial Sloan Kettering Cancer Center.

Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells

Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.

Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.

Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.

Escalating costs are hitting patients hard. CMS price negotiation and the $2,000 cap on Part D out-of-pocket expenses should benefit many patients with Medicare coverage.

Taiho’s Lytgobi is approved to treat advanced or metastatic advanced bile duct cancer in patients with FGFR2 gene fusions.

Jing Yang from IQVIA discusses how national payers are using formulary exclusions for oncology therapeutics.

Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.

Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.

While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.

Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.

This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.

There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.

Approved in May 2022, Tibsovo is the first therapy targeting cancer metabolism for older patients with newly diagnosed IDH1-mutated acute myeloid leukemia.

The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.

A Texas judge ruled that coverage for HIV pre-exposure prophylaxis (PrEP) violates religious freedom but there is concern that cancer screenings and other preventive services could be affected.