Fda approvals in ntrk-fusion cancers, aml, and saa, and priority review in aml gas examples

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The FDA has granted an accelerated approval to larotrectinib, known by the trade name Vitrakvi, for the treatment of adult and pediatric patients with solid tumors that harbor an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following therapy.

The decision is based on findings from patients with TRK-positive tumors who were enrolled across 3 clinical trials: phase I adult LOXO-TRK-14001 trial, the phase II NAVIGATE trial, and the phase I/II SCOUT pediatric trial. electricity lessons ks1 In data that were published in the New England Journal of Medicine in February 2018, larotrectinib was associated with an objective response rate of 75% by independent review and 80% by investigator assessment in 55 evaluable patients. In the independent assessment, there were 7 complete responses, 34 partial responses, and 7 patients with stable disease.

The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly diagnosed acute myeloid leukemia. The indication is specific to those who are aged 75 years or older, or have comorbidities that preclude use of intensive induction chemotherapy.

The decision is based on 2 phase Ib/II trials in this setting, which were the M14-358 study and the M14-387 study. In M14-358, the combination of venetoclax and azacitidine led to a complete remission rate of 37% and a CR with partial hematological recovery rate of 24%. The rates were 54% and 7.7%, respectively, with the combination of venetoclax and decitabine.

The approval was based on the phase II BRIGHT 1003 trial, in which 115 patients with newly diagnosed AML were randomized in a 2:1 ratio to receive glasdegib plus LDAC or LDAC alone. electricity labs for middle school Results showed that the addition of glasdegib to LDAC reduced the risk of death by 54% compared with LDAC alone. Additionally, the median overall survival was 8.3 months versus 4.3 months, respectively, and the complete response rate was 18.2% with the glasdegib combination compared with 2.6% with LDAC alone.

The FDA has expanded the approval of eltrombopag in combination with standard immunosuppressive therapy to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia. gas pain The agency also granted the agent a breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome.

The decision is based on a Novartis analysis sponsored by the National Heart, Lung, and Blood Institute Division of Intramural Research Program and conducted under a Cooperative Research and Development Agreement. Results showed that treatment with eltrombopag given concurrently with standard IST led to an overall response rate at 6 months of 79%.

Eltrombopag is an oral thrombopoietin receptor agonist with a prior indication for patients with SAA who have had an insufficient response to standard therapy, for adults and pediatric patients with chronic immune thrombocytopenia who are refractory to other therapies, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.

And this weekend, stay tuned for our News Network: On Location broadcast at the 2018 ASH Annual Meeting in San Diego, California! We’ll be recapping the top news presented each day during the meeting and interviewing key opinion leaders for their insight on some of the pivotal abstracts. To register for a reminder when the broadcast goes live, visit onclive.com/live.

The FDA has granted an accelerated approval to larotrectinib, known by the trade name Vitrakvi, for the treatment of adult and pediatric patients with solid tumors that harbor an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following therapy.

The decision is based on findings from patients with TRK-positive tumors who were enrolled across 3 clinical trials: phase I adult LOXO-TRK-14001 trial, the phase II NAVIGATE trial, and the phase I/II SCOUT pediatric trial. In data that were published in the New England Journal of Medicine in February 2018, larotrectinib was associated with an objective response rate of 75% by independent review and 80% by investigator assessment in 55 evaluable patients. electricity 4th grade In the independent assessment, there were 7 complete responses, 34 partial responses, and 7 patients with stable disease.

The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly diagnosed acute myeloid leukemia. The indication is specific to those who are aged 75 years or older, or have comorbidities that preclude use of intensive induction chemotherapy.

The decision is based on 2 phase Ib/II trials in this setting, which were the M14-358 study and the M14-387 study. gas constant for helium In M14-358, the combination of venetoclax and azacitidine led to a complete remission rate of 37% and a CR with partial hematological recovery rate of 24%. The rates were 54% and 7.7%, respectively, with the combination of venetoclax and decitabine.

The approval was based on the phase II BRIGHT 1003 trial, in which 115 patients with newly diagnosed AML were randomized in a 2:1 ratio to receive glasdegib plus LDAC or LDAC alone. Results showed that the addition of glasdegib to LDAC reduced the risk of death by 54% compared with LDAC alone. Additionally, the median overall survival was 8.3 months versus 4.3 months, respectively, and the complete response rate was 18.2% with the glasdegib combination compared with 2.6% with LDAC alone.

The FDA has expanded the approval of eltrombopag in combination with standard immunosuppressive therapy to include newly diagnosed adult and pediatric patients 2 years and older with severe aplastic anemia. The agency also granted the agent a breakthrough therapy designation as a counter measure for hematopoietic sub-syndrome of acute radiation syndrome.

The decision is based on a Novartis analysis sponsored by the National Heart, Lung, and Blood Institute Division of Intramural Research Program and conducted under a Cooperative Research and Development Agreement. Results showed that treatment with eltrombopag given concurrently with standard IST led to an overall response rate at 6 months of 79%.

Eltrombopag is an oral thrombopoietin receptor agonist with a prior indication for patients with SAA who have had an insufficient response to standard therapy, for adults and pediatric patients with chronic immune thrombocytopenia who are refractory to other therapies, and for the treatment of thrombocytopenia in patients with chronic hepatitis C virus infection.

And this weekend, stay tuned for our News Network: On Location broadcast at the 2018 ASH Annual Meeting in San Diego, California! We’ll be recapping the top news presented each day during the meeting and interviewing key opinion leaders for their insight on some of the pivotal abstracts. To register for a reminder when the broadcast goes live, visit onclive.com/live.