Oncology

This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.

Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.

Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.

The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.

The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.

Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.

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.

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.

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

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.

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.

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.

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.