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Priority Review Designation in NSCLC, Fast Track Designation in AML, CRL Issued for a Biosimilar, and More

Gina Columbus
Published: Friday, Oct 13, 2017



Today-

A priority review designation in non–small cell lung cancer, a fast track designation in acute myeloid leukemia, a breakthrough therapy designation in lung cancer, FDA approvals sought in prostate cancer and ovarian cancer, and a complete response letter issued for a biosimilar.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has granted a priority review to a supplemental new drug application for afatinib for the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

These uncommon mutations represent less than 10% of the EGFR mutations found in patients with NSCLC, but are associated with poor prognosis and survival.

Boehringer Ingelheim, the developer of afatinib, submitted data from the LUX-Lung 2, 3, and 6 trials to support the sNDA. A post-hoc analysis examined 75 patients across the 3 trials who received afatinib and were positive for uncommon EGFR mutations.

Investigators stratified patients with point mutations or duplications in exons 18 to 21 into group 1, patients with de-novo Thr790Met mutations in exon 20 alone or in combination with other mutations into group 2, and those with exon 20 insertions as group 3.

The median progression-free survival was 10.7 months in group 1, 2.9 months, in group 2, and 2.7 months in group 3. Additionally, the median overall survival was 19.4 months in group 1 compared with 14.9 months in group 2, and 9.2 months in group 3.

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In acute myeloid leukemia, the FDA has granted fast track designation to the investigational compound gilteritinib for adult patients with FLT3 mutation-positive relapsed/refractory disease.

The designation is based on results from a phase I/II dose-escalation and dose-expansion study, in which the research team observed antidisease activity at all dose levels with gilteritinib.

Of the 249 patients included in the full analysis, 40% had a response to treatment including 19 who had a complete response, 10 who had complete remission with incomplete platelet recovery, 46 who had complete remission with incomplete hematological recovery, and 25 who had partial remission.

The fast track program is designed to accelerate the development, review, and approval of drugs that treat serious and life-threatening conditions.

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The FDA has awarded a breakthrough therapy designation to osimertinib for the first-line treatment of patients with metastatic EGFR-positive non–small cell lung cancer.

Frontline osimertinib was associated with a 54% reduction in the risk of progression or death compared with standard erlotinib or gefitinib, according to phase III data from the FLAURA study that was reported at the 2017 ESMO Congress.

AstraZeneca, the manufacturer of osimertinib, submitted data from the double-blind FLAURA trial to support its biologics license application, which investigated the third-generation, irreversible EGFR tyrosine kinase inhibitor in treatment-naïve patients with locally advanced or metastatic EGFR mutation-positive NSCLC.

Results showed that the median progression-free survival was 18.9 months for osimertinib versus10.2 months for the control group. Improvements were seen in all pre-specified subgroups, including patients with and without brain metastases.

*****************************************

In prostate cancer, a new drug application was submitted to the FDA for apalutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

The application for apalutamide, a next-generation oral androgen receptor inhibitor, included data from the pivotal phase III SPARTAN trial. The study evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen level despite receiving continuous androgen deprivation therapy.

Janssen Biotech plans to release results from the SPARTAN trial at a future medical meeting. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, according to Janssen.

*************************************

A supplemental new drug application has been submitted to the FDA for rucaparib as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

The sNDA is based on findings from the phase III ARIEL3 trial, in which the PARP inhibitor improved median progression-free survival by 11.2 months versus placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer.

Additionally, for patients with germline or somatic BRCA mutations, there was a 77% reduction in the risk of progression or death with rucaparib versus placebo. The median PFS with rucaparib for this subset was 16.6 months compared with 5.4 months for placebo. Similar PFS benefits were observed in patients with BRCA wild-type tumors and those with homologous recombination deficiency or low to high loss of heterozygosity.

Rucaparib is currently approved by the FDA as a monotherapy for patients with ovarian cancer with a deleterious BRCA mutation following prior treatment with 2 or more chemotherapies.

*****************************************

Biocon announced that the FDA has issued a complete response letter for Mylan’s biologics license application for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim.

The company issued a statement reporting that the CRL relates to a pending update of the BLA to include information regarding facility requalification activities taken since the addition of recent plant modifications.

Biocon is developing MYL-1401H in partnership with Mylan, and the companies filed the application in February 2017. Originally, the FDA set a deadline to issue a decision on MYL-1401H by October 9 under the Biosimilar User Fee Act.

MYL-1401H is 1 of 6 biosimilars the companies are developing together.

Pegfilgrastim is FDA approved to decrease the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

*****************************************

This week, we sat down with Dr Sara Martin of Vanderbilt University to discuss the importance of palliative care and how it has demonstrated improvements in overall survival for patients with cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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Today-

A priority review designation in non–small cell lung cancer, a fast track designation in acute myeloid leukemia, a breakthrough therapy designation in lung cancer, FDA approvals sought in prostate cancer and ovarian cancer, and a complete response letter issued for a biosimilar.

Welcome to OncLive News Network! I’m Gina Columbus.

The FDA has granted a priority review to a supplemental new drug application for afatinib for the frontline treatment of patients with metastatic non–small cell lung cancer whose tumors harbor EGFR exon 21 (L861Q), G719X, or S768I substitution mutations.

These uncommon mutations represent less than 10% of the EGFR mutations found in patients with NSCLC, but are associated with poor prognosis and survival.

Boehringer Ingelheim, the developer of afatinib, submitted data from the LUX-Lung 2, 3, and 6 trials to support the sNDA. A post-hoc analysis examined 75 patients across the 3 trials who received afatinib and were positive for uncommon EGFR mutations.

Investigators stratified patients with point mutations or duplications in exons 18 to 21 into group 1, patients with de-novo Thr790Met mutations in exon 20 alone or in combination with other mutations into group 2, and those with exon 20 insertions as group 3.

The median progression-free survival was 10.7 months in group 1, 2.9 months, in group 2, and 2.7 months in group 3. Additionally, the median overall survival was 19.4 months in group 1 compared with 14.9 months in group 2, and 9.2 months in group 3.

*****************************************

In acute myeloid leukemia, the FDA has granted fast track designation to the investigational compound gilteritinib for adult patients with FLT3 mutation-positive relapsed/refractory disease.

The designation is based on results from a phase I/II dose-escalation and dose-expansion study, in which the research team observed antidisease activity at all dose levels with gilteritinib.

Of the 249 patients included in the full analysis, 40% had a response to treatment including 19 who had a complete response, 10 who had complete remission with incomplete platelet recovery, 46 who had complete remission with incomplete hematological recovery, and 25 who had partial remission.

The fast track program is designed to accelerate the development, review, and approval of drugs that treat serious and life-threatening conditions.

**************************************

The FDA has awarded a breakthrough therapy designation to osimertinib for the first-line treatment of patients with metastatic EGFR-positive non–small cell lung cancer.

Frontline osimertinib was associated with a 54% reduction in the risk of progression or death compared with standard erlotinib or gefitinib, according to phase III data from the FLAURA study that was reported at the 2017 ESMO Congress.

AstraZeneca, the manufacturer of osimertinib, submitted data from the double-blind FLAURA trial to support its biologics license application, which investigated the third-generation, irreversible EGFR tyrosine kinase inhibitor in treatment-naïve patients with locally advanced or metastatic EGFR mutation-positive NSCLC.

Results showed that the median progression-free survival was 18.9 months for osimertinib versus10.2 months for the control group. Improvements were seen in all pre-specified subgroups, including patients with and without brain metastases.

*****************************************

In prostate cancer, a new drug application was submitted to the FDA for apalutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

The application for apalutamide, a next-generation oral androgen receptor inhibitor, included data from the pivotal phase III SPARTAN trial. The study evaluated the safety and efficacy of apalutamide versus placebo in patients with a rapidly rising prostate specific antigen level despite receiving continuous androgen deprivation therapy.

Janssen Biotech plans to release results from the SPARTAN trial at a future medical meeting. Currently, there are no FDA-approved treatments for patients with nonmetastatic CRPC, according to Janssen.

*************************************

A supplemental new drug application has been submitted to the FDA for rucaparib as a maintenance therapy for patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

The sNDA is based on findings from the phase III ARIEL3 trial, in which the PARP inhibitor improved median progression-free survival by 11.2 months versus placebo for patients with BRCA-mutant platinum-sensitive ovarian cancer.

Additionally, for patients with germline or somatic BRCA mutations, there was a 77% reduction in the risk of progression or death with rucaparib versus placebo. The median PFS with rucaparib for this subset was 16.6 months compared with 5.4 months for placebo. Similar PFS benefits were observed in patients with BRCA wild-type tumors and those with homologous recombination deficiency or low to high loss of heterozygosity.

Rucaparib is currently approved by the FDA as a monotherapy for patients with ovarian cancer with a deleterious BRCA mutation following prior treatment with 2 or more chemotherapies.

*****************************************

Biocon announced that the FDA has issued a complete response letter for Mylan’s biologics license application for MYL-1401H, a proposed biosimilar for Amgen’s pegfilgrastim.

The company issued a statement reporting that the CRL relates to a pending update of the BLA to include information regarding facility requalification activities taken since the addition of recent plant modifications.

Biocon is developing MYL-1401H in partnership with Mylan, and the companies filed the application in February 2017. Originally, the FDA set a deadline to issue a decision on MYL-1401H by October 9 under the Biosimilar User Fee Act.

MYL-1401H is 1 of 6 biosimilars the companies are developing together.

Pegfilgrastim is FDA approved to decrease the incidence of infection as manifested by febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

*****************************************

This week, we sat down with Dr Sara Martin of Vanderbilt University to discuss the importance of palliative care and how it has demonstrated improvements in overall survival for patients with cancer.

That’s all for today.

Thank you for watching OncLive News Network! I’m Gina Columbus.
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