Sonrotoclax

BEQALZI is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). BEQALZI is a BCL-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.

Sonrotoclax is an inhibitor of B-cell lymphoma 2 (BCL-2) protein. Overexpression of BCL-2 in various cancers mediates cell survival and has been associated with chemotherapeutic resistance. Sonrotoclax binds to the BCL-2 protein, displacing pro-apoptotic proteins, thereby inducing apoptosis of cells. In nonclinical studies, sonrotoclax demonstrated cytotoxicity in cancer cells overexpressing BCL-2, with a series of intrinsic apoptotic events, including caspase activation.

Recommended dosage: 320 mg orally once daily following completion of a 4-week dose ramp-up schedule. Swallow tablets whole with food and water. Do not break, chew, or crush tablets. Provide prophylaxis for tumor lysis syndrome. See Full Prescribing Information for dosage modifications.

Concomitant use of sonrotoclax with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated in patients due to the potential for increased risk of tumor lysis syndrome. Concomitant use of sonrotoclax with strong CYP3A inhibitors at initiation and during the ramp-up phase is contraindicated.

Tumor Lysis Syndrome (TLS): Anticipate TLS, assess risk in all patients. Premedicate with anti-hyperuricemics, ensure adequate hydration, and monitor. Serious Infections: Monitor for infection and treat promptly. Neutropenia: Monitor blood counts regularly. Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Lysis Syndrome Serious Infections Neutropenia The most common adverse reactions (≥15%) are pneumonia and fatigue. The most common Grade 3-4 laboratory abnormalities (≥15%) are decreases in lymphocytes and neutrophils.

Strong CYP3A inhibitors: Contraindicated at initiation and during the ramp-up phase. Reduce target dose after ramp-up. Moderate CYP3A inhibitors: Avoid concomitant use at 1 mg and 2 mg doses of BEQALZI and reduce all other doses. Strong or moderate CYP3A inducers: Avoid coadministration.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Storage of blister wallets: Store tablets in the original blister package, do not transfer the tablets to a different container.