I’m thrilled to share that the U.S. Food & Drug Administration (FDA) has approved VARUBI® (rolapitant) IV in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. The news release that we just issued is attached to this note, and includes additional information, including important safety information.
Chemotherapy-induced nausea and vomiting (CINV) is a debilitating, yet often preventable, side effect of chemotherapy. VARUBI is a highly selective and competitive antagonist of human substance P/neurokinin 1 (NK-1) receptors, which play an important role in the delayed phase of CINV. With a long plasma half-life of approximately seven days, a single dose of VARUBI, as part of an antiemetic regimen, significantly improved complete response (CR) rates in the delayed phase of CINV.
On behalf of TESARO, I would like to thank the patients and caregivers who took part in the clinical trials that made this approval possible. Participating in a clinical trial is a selfless decision that has the potential to positively impact thousands of lives, and we are grateful for the compassion they show in accepting this role.
TESARO is committed to supporting people bravely facing cancer and we are working with patients, healthcare providers and payers to ensure access to VARUBI. We are committed to providing patients access to our medicines and will make VARUBI IV commercially available in the U.S. in November.
Thank you for your continued partnership! Organizations like SGNO inspire us every day to continue in our mission of providing transformative therapies to people bravely facing cancer. Relationships are vital to the success of our business, and we are committed to being a trusted partner to the cancer community. We are proud to share this exciting advancement with you, and as always, thank you for your ongoing dedication to supporting patients and caregivers facing cancer.
Sheryl Lapidus, MAG
Director, Corporate Affairs
TESARO, 1000 Winter St North, Waltham, MA 02451
Press Release: VARUBI IV Approval
Additional Information: NDA 208399 rolapitant inj
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Sydney, Australia, 2-6 October, 2018
Join us for the 32nd International Papillomavirus Conference, to be held October 2nd - 6th in Sydney, Australia. IPVC 2018 will gather researchers, clinicians and other health professionals to share knowledge and ideas on papillomaviruses and their associated diseases as we work towards global control of HPV disease. As with past IPVS conferences, IPVC 2018 will include an outstanding program of invited lectures, oral abstract sessions, poster sessions, symposia, workshops and social events.
We look forward to seeing you in Sydney!