Orphan diseases are characterized by high unmet need and small patient populations affecting fewer than 200,000 people.2 In the U.S., approximately 2,900 new cases of MCL are diagnosed each year3 with a median age at diagnosis of 65.4 MCL typically involves the lymph nodes, but can spread to other tissues, such as the bone marrow, liver, spleen and gastrointestinal tract.5 This challenging disease