2 new FDA indications March 2017

The FDA approved one new drug and gave a new indication for a previously approved drug in March 2017.

The FDA approved a new drug, called ribociclib for use in metastatic hormone-positive breast cancer. Ribociclib is a pill that inhibits CDK 4/6 similar to a previously approved drug, palbociclib, that we wrote about previously. http://www.meansadv03.com/hoaa-pharmacy/palbociclib-and-hormonal-therapy-has-proven-progression-free-survival-benefit/ Side effects were similar for ribociclib to palbociclib, so I do not think this revolutionizes care; but instead, affirms that most patients with new metastatic hormone-positive breast cancer should be treated with one of these drugs, along with hormone therapy.


The FDA approved pembrolizumab–a PD-1 inhibitor already used in melanoma, lung cancer, head and neck cancer—for use in Hodgkin Lymphoma that has been refractory to multiple prior chemotherapy regimens. In this population, pembrolizumab led to a partial response in up to 47% of patients, which is a great number in a refractory population of patients like this. This is the second immunotherapy to be approved in Hodgkin Lymphoma, which reinforces the idea that Hodgkin Disease is a cancer that is quite dependent on the immune system to grow.