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FDA Approvals in Hematologic Malignancies, sBLA Accepted in Multiple Myeloma, and More

Gina Columbus
Published: Friday, Jun 23, 2017



Today-

FDA approvals in hematologic malignancies, a supplemental biologics application accepted for a drug in multiple myeloma, promising findings in thyroid cancer and ovarian cancer, an approval sought in cutaneous T-cell lymphoma, and a European approval in non-Hodgkin lymphoma.

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

The FDA has approved subcutaneous rituximab for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated chronic lymphocytic leukemia.

In a statement, Genentech, the manufacturer of the treatment, said that the novel co-formulation includes the identical monoclonal antibody as intravenous rituximab, along with the molecule hyaluronidase, which facilitates the delivery of medicine beneath the skin.

The approval, which follows a positive recommendation from the FDA’s Oncologic Drugs Advisory Committee, is based on data from 5 clinical trials that included 2000 patients with the various blood cancers for which rituximab IV is currently approved. The results demonstrated that the efficacy, safety, and pharmacokinetics of the subcutaneous formulation were noninferior to IV rituximab.

Genentech said that new subcutaneous formula will be available in the United States in 1 to 2 weeks, and the IV formulation will continue to be available.

The FDA has also approved daratumumab for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.

The decision is based on data from the phase I EQUULEUS trial, in which the overall response rate was 59% with the daratumumab triplet in patients with relapsed/refractory disease.

The very good partial response rate was 28%, the complete response rate was 6%, and the stringent CR rate was 8%. The median time to response was 1 month, and the median duration of response was 13.6 months.

The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.

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

In multiple myeloma, the FDA accepted a supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events.

The sBLA is based on data from the phase III 482 study, in which the RANK ligand inhibitor demonstrated noninferiority to zoledronic acid, at delaying the time to the first SRE in patients with multiple myeloma.

The median time to first on-study SRE was similar between the treatments, at 22.83 months with denosumab versus 23.98 months with the bisphosphonate zoledronic acid. The median progression-free survival was 10.7 month higher in the denosumab arm. There was also a nonstatistically significant trend in overall survival favoring denosumab.

Under the Prescription Drug User Fee Act, a final decision from the FDA on the application is scheduled by February 3, 2018.

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

In thyroid cancer, lenvatinib was found to significantly improve overall survival in patients older than 65 years with radioiodine-refractory differentiated disease, according to recently published findings from the SELECT trial.

Compared with placebo, lenvatinib was associated with a significant improvement in OS in older patients. When stratified by age, only older patients in the placebo arm achieved the median OS of 18.4 months. Additionally, survival data were not mature for younger patients.

Investigators noted a statistically significant longer OS in patients younger than 65 years compared with older patients in the placebo arm. OS was not significantly different between age groups in the lenvatinib arm.

In 2015, the FDA approved lenvatinib in 2015 as a treatment for patients with progressive, radioactive iodine-refractory differentiated thyroid cancer based on initial progression-free survival results from SELECT, which showed that the drug reduced progression by 79% versus placebo.

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

Phase III findings from the ARIEL3 trial showed that the PARP inhibitor rucaparib improved progression-free survival versus placebo as a maintenance treatment for women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.

The results were announced by Clovis Oncology, the manufacturer of rucaparib, which also added that it expects to deliver expanded results at a medical meeting later this year.

Investigators found that treatment with rucaparib resulted in longer PFS for the intent-to-treat population, as well as patients positive for homologous recombination deficiency and those with BRCA mutant tumors, including germline and somatic mutations of BRCA. The HRD-positive population included BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity patients.

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

A supplemental biologics license application has been submitted to the FDA for brentuximab vedotin as a treatment for patients with cutaneous T-cell lymphoma.

The sBLA is primarily based on the phase III ALCANZA trial, in which brentuximab vedotin induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician’s choice of standard therapies.

The international, open-label phase III ALCANZA trial included 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma, the 2 most common subtypes of CTCL.

At a median follow-up of 22.9 months, the median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician’s choice. The ORR was 67% versus 20%, with CR rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively.

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

Finally, in non-Hodgkin lymphoma, the European Commission approved the rituximab biosimilar Rixathon to treat patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Rixathon is approved for use in all indications of the reference medicine, subcutaneous rituximab, which has been available in the European Union since 2014, and is approved in nearly 50 other countries.

The approval is based on results from the phase III confirmatory ASSIST-FL study, which compared the efficacy, safety, pharmacokinetics and pharmacodynamics of Rixathon plus cyclophosphamide, vincristine, prednisone versus rituximab-CVP in patients with previously untreated, advanced stage follicular lymphoma.

The overall response rate was 87.1% in the GP2013-CVP arm versus 87.5% in the rituximab-CVP arm. The rate of complete response was 14.8% and the partial response rate was 72.3% in the GP2013-CVP arm. Complete response rate was 13.4% with a partial response rate of 74.1% in the rituximab-CVP group.

The median progression-free survival and overall survival had not been reached.

The EU approval for Rixathon also includes indications for immunological diseases, such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiiti.

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

This week, Dr. Christine Lovly of Vanderbilt-Ingram Cancer Center discussed the utility and promise of osimertinib in non–small cell lung cancer.

That’s all for today.

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

FDA approvals in hematologic malignancies, a supplemental biologics application accepted for a drug in multiple myeloma, promising findings in thyroid cancer and ovarian cancer, an approval sought in cutaneous T-cell lymphoma, and a European approval in non-Hodgkin lymphoma.

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

The FDA has approved subcutaneous rituximab for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated chronic lymphocytic leukemia.

In a statement, Genentech, the manufacturer of the treatment, said that the novel co-formulation includes the identical monoclonal antibody as intravenous rituximab, along with the molecule hyaluronidase, which facilitates the delivery of medicine beneath the skin.

The approval, which follows a positive recommendation from the FDA’s Oncologic Drugs Advisory Committee, is based on data from 5 clinical trials that included 2000 patients with the various blood cancers for which rituximab IV is currently approved. The results demonstrated that the efficacy, safety, and pharmacokinetics of the subcutaneous formulation were noninferior to IV rituximab.

Genentech said that new subcutaneous formula will be available in the United States in 1 to 2 weeks, and the IV formulation will continue to be available.

The FDA has also approved daratumumab for use in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide.

The decision is based on data from the phase I EQUULEUS trial, in which the overall response rate was 59% with the daratumumab triplet in patients with relapsed/refractory disease.

The very good partial response rate was 28%, the complete response rate was 6%, and the stringent CR rate was 8%. The median time to response was 1 month, and the median duration of response was 13.6 months.

The FDA previously approved daratumumab in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.

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

In multiple myeloma, the FDA accepted a supplemental biologics license application for the use of denosumab for the prevention of skeletal-related events.

The sBLA is based on data from the phase III 482 study, in which the RANK ligand inhibitor demonstrated noninferiority to zoledronic acid, at delaying the time to the first SRE in patients with multiple myeloma.

The median time to first on-study SRE was similar between the treatments, at 22.83 months with denosumab versus 23.98 months with the bisphosphonate zoledronic acid. The median progression-free survival was 10.7 month higher in the denosumab arm. There was also a nonstatistically significant trend in overall survival favoring denosumab.

Under the Prescription Drug User Fee Act, a final decision from the FDA on the application is scheduled by February 3, 2018.

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

In thyroid cancer, lenvatinib was found to significantly improve overall survival in patients older than 65 years with radioiodine-refractory differentiated disease, according to recently published findings from the SELECT trial.

Compared with placebo, lenvatinib was associated with a significant improvement in OS in older patients. When stratified by age, only older patients in the placebo arm achieved the median OS of 18.4 months. Additionally, survival data were not mature for younger patients.

Investigators noted a statistically significant longer OS in patients younger than 65 years compared with older patients in the placebo arm. OS was not significantly different between age groups in the lenvatinib arm.

In 2015, the FDA approved lenvatinib in 2015 as a treatment for patients with progressive, radioactive iodine-refractory differentiated thyroid cancer based on initial progression-free survival results from SELECT, which showed that the drug reduced progression by 79% versus placebo.

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

Phase III findings from the ARIEL3 trial showed that the PARP inhibitor rucaparib improved progression-free survival versus placebo as a maintenance treatment for women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.

The results were announced by Clovis Oncology, the manufacturer of rucaparib, which also added that it expects to deliver expanded results at a medical meeting later this year.

Investigators found that treatment with rucaparib resulted in longer PFS for the intent-to-treat population, as well as patients positive for homologous recombination deficiency and those with BRCA mutant tumors, including germline and somatic mutations of BRCA. The HRD-positive population included BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity patients.

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

A supplemental biologics license application has been submitted to the FDA for brentuximab vedotin as a treatment for patients with cutaneous T-cell lymphoma.

The sBLA is primarily based on the phase III ALCANZA trial, in which brentuximab vedotin induced responses lasting at least 4 months in 56.3% of patients versus 12.5% in patients receiving physician’s choice of standard therapies.

The international, open-label phase III ALCANZA trial included 131 patients with CD30-expressing mycosis fungoides or primary cutaneous anaplastic large cell lymphoma, the 2 most common subtypes of CTCL.

At a median follow-up of 22.9 months, the median progression-free survival was 16.7 months with brentuximab vedotin versus 3.5 months with physician’s choice. The ORR was 67% versus 20%, with CR rates of 16% versus 2%, in the brentuximab vedotin and control arms, respectively.

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

Finally, in non-Hodgkin lymphoma, the European Commission approved the rituximab biosimilar Rixathon to treat patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.

Rixathon is approved for use in all indications of the reference medicine, subcutaneous rituximab, which has been available in the European Union since 2014, and is approved in nearly 50 other countries.

The approval is based on results from the phase III confirmatory ASSIST-FL study, which compared the efficacy, safety, pharmacokinetics and pharmacodynamics of Rixathon plus cyclophosphamide, vincristine, prednisone versus rituximab-CVP in patients with previously untreated, advanced stage follicular lymphoma.

The overall response rate was 87.1% in the GP2013-CVP arm versus 87.5% in the rituximab-CVP arm. The rate of complete response was 14.8% and the partial response rate was 72.3% in the GP2013-CVP arm. Complete response rate was 13.4% with a partial response rate of 74.1% in the rituximab-CVP group.

The median progression-free survival and overall survival had not been reached.

The EU approval for Rixathon also includes indications for immunological diseases, such as rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiiti.

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

This week, Dr. Christine Lovly of Vanderbilt-Ingram Cancer Center discussed the utility and promise of osimertinib in non–small cell lung cancer.

That’s all for today.

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