Zepzelca approved in U.S., second-line treatment for metastatic small cell lung cancer
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Last Update: 2020-06-25
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Source: Internet
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Author: User
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Jazz Pharmaceuticals and its partner PharmaMar announced thatFDAhas approved Zepzelca (lurbinectin) for the treatment of metastatic small cell lung cancer (SCLC) in adult patients with disease progression in or after chemotherapyZepzelca is an alkylate drug that binds to the remains of the bird in THE DNA to inhibit cancer-causing transcription in tumor-related macrophagesThe compound has previously been given priority review by U.Sregulators and named as an orphan drugThe FDA's decision was supported by single-drug treatment data from the Single Arm II study, which evaluated 105 platinum-sensitive and platinum-resistant SCLC patients with disease progression after platinum chemotherapyThe results, published last month in the journal Lancet Oncology, showed that zepzelca had an overall remission rate (ORR) of 35 percent and a median remission duration of 5.3 months in patients with SCLC recurrenceThe ORR of platinum-sensitive or drug-resistant patients was 45% and 22.2% respectivelyBruce Cozadd, chief executive of Jazz, noted that SCLC patients are currently "limited in treatment options, so the approval of Zepzelca represents an important step forward for patients with recurrent SCLC." Although patients may initially respond to traditional chemotherapy, the rate of invasive recurrence is highZepzelca will be available in the U.Sin early July, according to Jazz and PharmaMar
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