CALA - Calithera gains 16% as FDA awards Fast Track status for lung cancer candidate

• Calithera Biosciences, Inc. ( NASDAQ: CALA ) added ~16% pre-market Monday after the oncology-focused biotech announced that the FDA issued the Fast Track designation for sapanisertib as a treatment for adults with a certain type of lung cancer.
• Specifically, the FDA has offered the designation for sapanisertib to treat adults with unresectable or metastatic squamous non-small cell lung cancer with a particular genetic mutation in tumors and who have previously received chemotherapy and immune checkpoint inhibitors.
• The FDA offers the Fast Track designation to accelerate the development and review of drugs targeted at serious conditions with unmet medical needs. It allows developers to communicate frequently with the regulator on plans for clinical studies.
• If certain criteria are met, such programs will also be able to win the Accelerated Approval and Priority Review, enabling the treatments to reach patients sooner.
• In July, CALA announced that the patient recruitment started in Phase 2 for sapanisertib (CB-228), designed to study the candidate in certain patients with squamous non-small cell lung cancer.

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