Σάββατο, 13 Μαΐου 2017

LETROZOLE-RIBOCICLIB CO-PACKAGE APPROVED BY FDA

On May 8, the U.S. Food and Drug Administration (FDA) approved the copackaging of ribociclib (Kisqali) and letrozole (Femara) tablets for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal women. The ribociclib/letrozole co-pack is the first—and only currently available—combination pack with two prescription products in advanced breast cancer.
With this FDA approval, physicians in the United States now have the flexibility to prescribe ribociclib two different ways: via the new co-pack or as two separate prescriptions of ribociclib and any aromatase inhibitor. The co-pack allows patients the convenience of obtaining a full 28-day cycle of the two medicines—in one package, with one prescription, and one copay. The ribociclib/letrozole co-pack is available at the same cost as ribociclib alone.
The ribociclib/letrozole co-pack is available in three dosage strengths: ribociclib at 600 mg plus letrozole at 2.5 mg; ribociclib at 400 mg plus letrozole at 2.5 mg; and ribociclib at 200 mg plus letrozole at 2.5 mg. The ribociclib/letrozole co-pack does not change the indication for either medicine.


Ribociclib was approved by the FDA on March 13, 2017, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. Letrozole is an aromatase inhibitor approved for first-line treatment of postmenopausal women with hormone receptor–positive or hormone receptor–unknown advanced breast cancer.

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