Oncology

Real-world data show Erleada prolonged survival in both metastatic and non-metastatic castration-sensitive prostate cancer.

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.

Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.

Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.

Study results reported in JAMA Network Open show that financial incentives are only modestly effective in getting more people to get way screened for colorectal cancer.

The FDA has set a PDUFA date of December 23, 2021.

FDA approves Opdivo, Jardiance for new indication, Jemperli gets accelerated approval for solid tumors, and Lilly’s rapid-acting insulin, Lyumjev is approved for administration via an insulin pump.

The therapy is the first approved for patients with tumors associated with von Hippel-Lindau disease.

The therapy is expected to be available by early September.

Libtayo also reduced the risk of death by 29% compared with chemotherapy alone.

The graft-versus-host disease therapy has also been added to NCCN Guidelines.

The PDUFA date has been set for December 4, 2021; FDA has designated this as a Priority Review.

The PDUFA date for this indication is December 4, 2021.

The FDA is expected to make a decision on this indication by December 1, 2021.

The therapy had received accelerated approval in 2011 but a phase 3 confirmatory trial found it did not meet the end point of progression-free survival.

Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.

Drugs that provide only incremental benefit may not be included on clinical pathways.

Study shows that nonsmall cell lung cancer patients who smoke but quit after their diagnosis have better overall survival, progression-free survival than patients who continue to smoke.

The FDA would like to see additional data on clinical benefit for patients with anal cancer.

Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.

New vaccine for pneumococcal disease, an sNDA approved based on real-world data, a new therapy for skin and muscle disease, Keytruda combination receives full approval in endometrial cancer, a new diabetes therapy is approved, and another JAK inhibitor misses PDUFA date round out this week’s FDA news.

The June 30 approval meets an unmet need in this cancer.

The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.