Oncology

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

This is the second trial in less than a month studying Keytruda that failed to meet endpoints.

Investigators found that socioeconomic and financial barriers can affect patients’ access to oral cancer medications. They suggest that addressing these barriers could improve adherence.

The prescription drug launches include a therapy to treat adults with multiple myeloma and a treatment for overactive bladder. Dr. Reddy’s has also acquired several therapies from Eton Pharmaceuticals, including hypotension treatments.

The trial of the immunotherapy combination, although approved in other renal cell carcinoma indications, did not meet the endpoint of disease-free survival in patients with localized disease.

If approved, N-803 — with the brand name Anktiva — plus the Bacillus Calmette-Guérin vaccine would be the first immunotherapy combination for this indication in 23 years. The Prescription Drug User Fee Act target action date is May 23, 2023.

If approved, Enhertu would offer a treatment option for patients with breast cancer who have a lower expression of HER2. The PDUFA action date is during the fourth quarter of the 2022.

The KEYNOTE-412 study did not meet its primary endpoint of event-free survival.

An independent data monitoring committee made the recommendation to stop both arms of the trial after a planned interim analysis found the trial didn’t meet its objectives.

Pfizer’s Xalkori is now approved for three indications, with the most recent being ALK-positive myofibroblastic tumors

Although the Oncology Care Model produced some positive results, the value-based care model cost Medicare money. Now attention is turning to its successor, the Enhancing Oncology Model.

The FDA has not been able to complete inspections of facilities because of COVID-19 restrictions.

The FDA has assigned a Prescription Drug User Fee Act action date of May 12, 2023, for [vic-]trastuzumab duocarmazine (SYD985).

Bispecific antibody therapies are also in development.

If approved, mosunetuzumab could be the first T-cell engaging bispecific antibody for the treatment of any type of non-Hodgkin’s lymphoma. The FDA has assigned a PDUFA date of Dec. 29, 2022.

Final results from a phase 3 study found that Copiktra was associated with a higher risk of serious side effects, dose modifications, and deaths compared with Kesimpta.

Breyanzi is now available as a second-line treatment for this aggressive blood cancer.

Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.

The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.

A study in the journal Blood has found that the cost-effectiveness of the Polivy treatment regimen used to treat patients with diffuse large B-cell lymphoma would decrease if the five-year progression-free survival decreased.

Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.

Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.