Oncology

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.

But investigators found that U.S. approvals often come before publication of results.

The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.

The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.

The FDA approved Orgovyx in December 2021 to treat patients with advanced prostate cancer.

If biosimilar acceptance is to grow, it’s going to take a great deal of work to improve the levels of trust between payers, patients, and oncologists.

The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.

More than 5,700 trials worldwide are investigating PD-1/PD-L1 inhibitors, and new trials of these therapies were of combination regimens.

The FDA indicated the risk of death outweighs the benefits of Ukoniq, which was approved in February 2021 to treat specific lymphomas.

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.

Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.

The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.

This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.