Avella Selected by Clovis Oncology to Distribute Rubraca

PRESS RELEASE

Avella has announced that it has been selected by Clovis Oncology to distribute RUBRACA^TM, an oral therapy for ovarian cancer. The drug was recently approved by the FDA for patients with advanced ovarian cancer who have previously received two types of chemotherapy agents.

RUBRACA is a poly (ADP-ribose) polymerase (PARP) inhibitor. These types of drugs interfere with the replication of DNA in cancer cells, preventing the repair of cell damage and ultimately leading to cell death. It is specifically indicated for use in women who have an abnormal mutation in their BRCA genes, whether this mutation is inherited or acquired. Both BRCA1 and BRCA2 are genes involved in tumor suppression.

The FDA approved RUBRACA under its accelerated approval process based on the results for tumor response rates and the duration of response. Two clinical studies showed that when taking RUBRACA, patients with advanced BRCA-mutant ovarian cancer had a response rate of 54 percent and exhibited a 9.2-month mean duration of response.

Ovarian cancer accounts for approximately three percent of cancers among women, but has the highest fatality rate of any reproductive cancer in females. Woman who possess the BRCA mutation are at especially high risk. Thirty-nine percent of women who inherit BRCA1 mutations and 11-17 percent of women who inherit BRCA2 mutation will develop ovarian cancer by age 70.

“The diagnosis of advanced ovarian cancer can have a devastating impact on patients as well as their loved ones,” said Leslie Yendro, Vice President of Business Development at Avella. “Fortunately, with the introduction of new drugs like RUBRACA, we are gaining ground in this fight against a disease that has taken too many lives. Avella is excited to give oncologists access to a powerful new treatment as they work to extend survival and improve quality of life for their patients.”

The most common adverse reactions for Rubraca (≥ 20%; Grade 1-4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%), and thrombocytopenia (21%). Because of the potential for serious adverse reactions in breast-fed infants from Rubraca, lactating women are advised not to breastfeed during treatment with Rubraca and for 2 weeks after the final dose.