publication date: Jan. 15, 2021

Drugs & Targets

Xalkori receives FDA approval for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

FDA has approved Xalkori (crizotinib) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive.

Xalkori is sponsored by Pfizer. The safety and efficacy of crizotinib have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Efficacy was evaluated in Study ADVL0912 (NCT00939770), a multicenter, single-arm, open-label trial in patients 1 to ≤21 years of age that included 26 patients with relapsed or refractory, systemic ALK-positive ALCL after at least one systemic treatment. Patients received crizotinib 280 mg/m2 (20 patients) or 165 mg/m2 (6 patients) orally twice daily until disease progression or unacceptable toxicity. Patients were permitted to discontinue crizotinib to undergo hematopoietic stem cell transplantation.

Efficacy was based on objective response rate and duration of response as assessed by an independent review committee. The ORR in the 26 patients was 88% (95% CI: 71, 96), with a complete remission rate of 81%. Of the 23 patients who achieved a response, 39% maintained response for at least 6 months, and 22% maintained response for at least 12 months.

 

Pvsripo receives Orphan Drug Designation from FDA for advanced melanoma treatment

FDA has granted orphan drug designation to Pvsripo for the treatment of advanced melanoma (stage IIB-IV).

Pvsripo, a novel viral immunotherapy, is sponsored by Istari Oncology Inc.

Pvsripo is based on the Sabin type 1 polio vaccine that activates a patient’s innate and adaptive immune system to facilitate an anti-tumor response and … Continue reading Xalkori receives FDA approval for children and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma

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