Elevar Therapeutics, Inc. (“Elevar”), a
fully integrated biopharmaceutical company built on the promise of elevating
treatment experiences and outcomes for patients who have limited or inadequate
therapeutic options, today announced that the U.S. Food and Drug Administration
(FDA) has granted rivoceranib
(apatinib) with orphan drug designation for the treatment of adenoid cystic carcinoma
(ACC), a rare form of cancer that most commonly develops in the salivary glands
or other regions of the head and neck. Approximately
1,200 new cases of ACC are diagnosed each year in the United States.
The FDA’s Office
of Orphan Drug Products grants orphan status to medicines for underserved
patient populations, or rare disorders, that affect fewer than 200,000 people
in the U.S.
“We are pleased by
the FDA’s recognition of the critical need to develop treatments for adenoid cystic
carcinoma (ACC) given the progressive nature of the disease,’ said Alex Kim,
chief executive officer of Elevar. “The orphan drug designation provides further
momentum for the rivoceranib development program, which we are committed to
advancing as quickly as possible for patients in need.”
ACC is considered
a slow growing but relentless cancer that is characterized by nerve invasion
and metastases. Although good local control is usually achieved by resection of
the primary tumor and adjuvant radiation therapy, more than half of patients
eventually have recurrent and/or metastatic disease. Currently, no curative
treatments are available for these patients which underscores the need for
effective new therapies.
“With no approved
treatments for adenoid cystic carcinoma (ACC), a significant unmet need remains
for therapies that slow or stop this relentless disease,” said Mark Gelder,
M.D., chief medical officer of Elevar. “The orphan drug designation from the
FDA reinforces the urgency of Elevar’s work with rivoceranib in ACC and our
commitment to improving treatment experiences and outcomes for patients who
have limited or inadequate therapeutic options.”
In November 2020, Elevar announced that the Company met its initial 55 patient enrollment target for its Phase 2, open-label, multicenter, clinical trial of rivoceranib in patients with recurrent or metastatic ACC one year ahead of schedule. The Company also announced increasing the target size of the trial to approximately 72 patients to further explore the potential clinical benefit of rivoceranib in this patient population.