Oncology

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.

The therapy is approved for both adults and children.

Sixty percent of patients likely to move forward with a healthcare decision not recommended by their physician, according to a TrialJectory Survey.

When wondering what step to take first after learning of your cancer diagnosis, assembling the right care team and creating a treatment plan designed uniquely is important to get you on the right track. Comprehensive biomarker testing can then help identify your type of lung cancer and help move steps forward for proper care.

The FDA’s accelerated pathway gets drugs to market quickly, but it also can mean patients are put on therapies that do not actually provide a clinical benefit.

Some see the upward trend in cancer drug costs as accelerating — and unsustainable. Value-based pathways might rearrange the incentives to put some downward pressure on prices.

An advisory committee recommends against approving an anemia drug. Darzalex Faspro receives another indication, Bayer receives approval for Kerendia for chronic kidney disease, and FDA delays its decision on sNDAs for JAK inhibitor therapies for atopic dermatitis.

Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.

After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.

A permanent code is expected in the third quarter of 2021.

The new indication provides a subcutaneous option for multiple myeloma that can be administrated in minutes, rather than hours.

Keytruda loses one indication but gains another, Biogen narrows use of Aduhelm, Padcev gets regular approval and expanded indication, Amgen submits application for asthma biologic, agency issues complete response letter for diabetes prevention therapy teplizumab, Novartis resubmits NDA for inclisiran.

This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.

Merck will withdraw Keytruda's advanced gastric indication after an FDA panel vote, a drug with supply problems gets a new indication, NDAs for an HIV therapy, and other news.

The therapy, a recombinant version, was developed to address supply and manufacturing issues.

Results suggest potential for better use of precision medicine approaches.