The designation marks the first Breakthrough Therapy recognition for calderasib and is backed by positive results from the Phase 1 KANDLELIT-001 clinical trial
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes
The Establishment Inspection Report came following closure of a product- specific pre-approval inspection from March 2 to March 7, 2026
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
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