Oncology

Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.

The FDA has asked for an additional clinical trial with overall survival as the endpoint.

The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.

Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.

In an interim analysis, Keytruda/Lynparza did not improve overall survival in patients with metastatic castration-resistant prostate cancer who progressed after treatment with chemotherapy.

After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.

Lynparza reduced the risk of death by 32% versus placebo. It is the first targeted treatment for patients with early breast cancer to be used after surgery or prior treatment.

Besremi is included as an option to treat the rare blood disorder polycythemia vera regardless of treatment history and for use in both low- and high-risk settings.

Aadi Bioscience recently launched Fyarro, the first FDA-approved therapy to treat an ultra-rare sarcoma.

This is the first generic available for Revlimid in the United States.

Amneal Pharmaceuticals received approval for Releuko to decrease incidence of infection after chemotherapy.

Despite the promise of savings billions of dollars in the United States, adoption of biosimilars has been slow. A roundtable discussion among employers highlighted some of the barriers, including formulary design and drug pricing and rebates.

Price increases on promising non–small cell lung cancer drugs despite evidence price competition raise concerns about affordability.

Reporting of PRO in oncology clinical trials increased after standards from ISOQOL and others were published in 2013.

Because of a COVID-19 related shortage, facilities may not have immediate access to Actemra, which is required as part of the REMS programs for CAR T-cell therapies.

Blood cancer patients who had at least some antibodies after the first two doses are likely to produce large amounts after the third vaccination.

Both Copiktra and Farydak had received accelerated approvals, and the FDA had required confirmatory trials. Secura Bio has determined such trials are not feasible.

The approval marks the ninth indication for Darzalex Faspro, the only subcutaneous anti-CD38 monoclonal antibody approved to treat multiple myeloma across multiple treatment regimens.

The warnings section of Inrebic, a JAK inhibitor to treat a bone marrow cancer, now includes information about the cardiovascular risk associated with Xeljanz, another JAK inhibitor to treat arthritis.

The regulatory agency has set a Prescription Drug User Fee Act date during the first quarter of 2022

Cytalux is the first imagining agent to illuminate ovarian cancer during surgery.

Keytruda is the first immunotherapy approved for treatment of patients with early renal cell carcinoma after surgery.

Most of the patients with no immune response after the two-dose regimen responded well to a third shot.

Patients with chronic lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, and multiple myeloma were more likely to have a COVID-19 breakthrough infection.

The studies conducted to support Verzenio’s most recent approval for the treatment of high-risk early breast cancer provided additional safety data.

The agency needs more time to review new information on the analytical method used.

Several generics of the cancer therapeutic are available.

Novartis’ Scemblix was approved for previously treated patients and for those who are resistant to TKI inhibitors.

Novatis is seeking approval for Kymriah in adult patients with advanced follicular lymphoma.

Cumulative spending on drugs without overall survival data was $1.8 billion in 2018 and surpassed that of drugs with such data.