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FDA Approvals in Myeloma and ITP, Applications Accepted in Myeloma and More

Gina Columbus
Published: Tuesday, Jul 16, 2019



Today-

FDA approvals in multiple myeloma and immune thrombocytopenia, applications accepted in multiple myeloma and for a new dosing schedule for a PD-1 inhibitor, and a European approval in cutaneous squamous cell carcinoma.

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

The FDA has granted an accelerated approval to selinexor, known by the trade name Xpovio, for use in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 or more immunomodulatory agents, and a CD38-targeted monoclonal antibody.

The approval is based on data from a prespecified subgroup analysis of part 2 of the single-arm, phase II STORM trial, in which the overall response rate was 25.3% as assessed by an Independent Review Committee, in 83 patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. Moreover, the stringent complete response rate was 1%, the very good partial response rate was 5%, and the partial response rate was 19%.

The approval is contingent on the results of a confirmatory trial, which is the phase III BOSTON study. This trial is evaluating the addition of selinexor to bortezomib and low-dose dexamethasone versus bortezomib/low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior regimens.

The approval follows a February 2018 FDA Oncologic Drugs Advisory Committee hearing, in which the committee voted 8 to 5 against approving the new drug application for selinexor, as it recommended the agency to delay a decision on the drug until the BOSTON data became available.

Additionally, the European Medicines Agency is also reviewing a Marketing Authorization Application for selinexor for this indication.

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In chronic immune thrombocytopenia, the FDA has approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients who have had an insufficient response to prior therapy.

The approval of the oral thrombopoietin receptor agonist was mainly based on results from a phase III trial, which showed that avatrombopag led to a platelet count of >50,000 per Mu-L after 8 days of therapy in the majority of patients with chronic ITP. It was also superior to placebo in maintaining platelet counts in the target range during a 6-month period.

The decision to approve avatrombopag was also supported by 2 phase II clinical trials and 2 phase III studies in thrombocytopenia in patients with chronic liver disease. Safety data were considered across the 24 studies in the avatrombopag clinical development program.

Avatrombopag was initially approved by the FDA in May 2018 as a treatment for thrombocytopenia in adults with CLD who are scheduled to undergo a medical or dental procedure.

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The FDA has accepted a biologics license application for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma.

The application is based on the phase III ICARIA-MM trial, in which adding isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death versus pomalidomide and dexamethasone alone in patients with relapsed/refractory disease.

Results showed that at a median follow-up of 11.6 months, the median progression-free survival per independent review was 11.53 months with the isatuximab regimen compared with 6.47 months with Pd alone.

Overall survival data were immature at the time of analysis; however, there was a trend toward a survival benefit for the isatuximab arm. The median OS was not reached in either arm, and the 1-year OS rate was 72% with the isatuximab triplet versus 63% with Pd alone.

The FDA is scheduled to make a decision on the BLA by April 30, 2020.

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

The FDA has accepted 6 supplemental biologics license applications for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma.

If approved, the updated dosing schedule would be available in addition to the standard 200 mg every-3-weeks schedule, which is also administered over a 30-minute infusion. The FDA must make a decision on the application by February 18, 2020.

In March 2019, the European Commission approved the 400 mg every-6-week dosing schedule in all of pembrolizumab’s single-agent indications, which also include non–small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, microsatellite instability–high or mismatch repair deficient solid tumors, and cervical cancer.

Results of a study evaluating the extended dosing schedule showed that the 2 dosing regimens are expected to have a similar benefit-risk profile, suggesting that physicians could have the flexibility to dose at a frequency that is personalized toward patients’ needs and/or personal preferences.

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

In cutaneous squamous cell carcinoma, the European Commission approved cemiplimab for the treatment of adult patients with metastatic or locally advanced disease who are not candidates for curative surgery or curative radiation.

The approval is primarily based on data from the phase II EMPOWER-CSCC-1 trial, which assessed single-agent cemiplimab in 78 patients with locally advanced CSCC and 59 patients with metastatic disease. At a median follow-up of 9 months, results showed that the objective response rate was 44% in the locally advanced group. In the metastatic group, the ORR was 49% at a median follow-up of 17 months.

Cemiplimab was granted conditional marketing authorization, therefore continued approval is contingent on additional information being supplied to the European Medicines Agency that support the drug’s benefit-risk profile. To comply, the manufacturers, Regeneron and Sanofi, are adding a new patient group to EMPOWER-CSCC-1 to obtain additional data.

The FDA approved cemiplimab for patients with CSCC in September 2018.

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

This week, we sat down with Dr Anthony Mato, of Memorial Sloan Kettering Cancer Center, to discuss recent breakthroughs in the treatment of patients with refractory CLL.

That’s all for today.

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

FDA approvals in multiple myeloma and immune thrombocytopenia, applications accepted in multiple myeloma and for a new dosing schedule for a PD-1 inhibitor, and a European approval in cutaneous squamous cell carcinoma.

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

The FDA has granted an accelerated approval to selinexor, known by the trade name Xpovio, for use in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 or more immunomodulatory agents, and a CD38-targeted monoclonal antibody.

The approval is based on data from a prespecified subgroup analysis of part 2 of the single-arm, phase II STORM trial, in which the overall response rate was 25.3% as assessed by an Independent Review Committee, in 83 patients whose disease was refractory to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab. Moreover, the stringent complete response rate was 1%, the very good partial response rate was 5%, and the partial response rate was 19%.

The approval is contingent on the results of a confirmatory trial, which is the phase III BOSTON study. This trial is evaluating the addition of selinexor to bortezomib and low-dose dexamethasone versus bortezomib/low-dose dexamethasone alone in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior regimens.

The approval follows a February 2018 FDA Oncologic Drugs Advisory Committee hearing, in which the committee voted 8 to 5 against approving the new drug application for selinexor, as it recommended the agency to delay a decision on the drug until the BOSTON data became available.

Additionally, the European Medicines Agency is also reviewing a Marketing Authorization Application for selinexor for this indication.

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

In chronic immune thrombocytopenia, the FDA has approved a supplemental new drug application to expand the use of avatrombopag to include the treatment of adult patients who have had an insufficient response to prior therapy.

The approval of the oral thrombopoietin receptor agonist was mainly based on results from a phase III trial, which showed that avatrombopag led to a platelet count of >50,000 per Mu-L after 8 days of therapy in the majority of patients with chronic ITP. It was also superior to placebo in maintaining platelet counts in the target range during a 6-month period.

The decision to approve avatrombopag was also supported by 2 phase II clinical trials and 2 phase III studies in thrombocytopenia in patients with chronic liver disease. Safety data were considered across the 24 studies in the avatrombopag clinical development program.

Avatrombopag was initially approved by the FDA in May 2018 as a treatment for thrombocytopenia in adults with CLD who are scheduled to undergo a medical or dental procedure.

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

The FDA has accepted a biologics license application for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma.

The application is based on the phase III ICARIA-MM trial, in which adding isatuximab to pomalidomide and low-dose dexamethasone led to a greater than 40% reduction in the risk of disease progression or death versus pomalidomide and dexamethasone alone in patients with relapsed/refractory disease.

Results showed that at a median follow-up of 11.6 months, the median progression-free survival per independent review was 11.53 months with the isatuximab regimen compared with 6.47 months with Pd alone.

Overall survival data were immature at the time of analysis; however, there was a trend toward a survival benefit for the isatuximab arm. The median OS was not reached in either arm, and the 1-year OS rate was 72% with the isatuximab triplet versus 63% with Pd alone.

The FDA is scheduled to make a decision on the BLA by April 30, 2020.

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

The FDA has accepted 6 supplemental biologics license applications for review to update the dosing schedule for pembrolizumab to include an every-6-weeks option at 400 mg over 30-minute infusions. The new dosage would be applicable for the PD-1 inhibitor’s following indications: melanoma, Merkel cell carcinoma, gastric cancer, hepatocellular carcinoma, classical Hodgkin lymphoma, and primary mediastinal large B-cell lymphoma.

If approved, the updated dosing schedule would be available in addition to the standard 200 mg every-3-weeks schedule, which is also administered over a 30-minute infusion. The FDA must make a decision on the application by February 18, 2020.

In March 2019, the European Commission approved the 400 mg every-6-week dosing schedule in all of pembrolizumab’s single-agent indications, which also include non–small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, microsatellite instability–high or mismatch repair deficient solid tumors, and cervical cancer.

Results of a study evaluating the extended dosing schedule showed that the 2 dosing regimens are expected to have a similar benefit-risk profile, suggesting that physicians could have the flexibility to dose at a frequency that is personalized toward patients’ needs and/or personal preferences.

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

In cutaneous squamous cell carcinoma, the European Commission approved cemiplimab for the treatment of adult patients with metastatic or locally advanced disease who are not candidates for curative surgery or curative radiation.

The approval is primarily based on data from the phase II EMPOWER-CSCC-1 trial, which assessed single-agent cemiplimab in 78 patients with locally advanced CSCC and 59 patients with metastatic disease. At a median follow-up of 9 months, results showed that the objective response rate was 44% in the locally advanced group. In the metastatic group, the ORR was 49% at a median follow-up of 17 months.

Cemiplimab was granted conditional marketing authorization, therefore continued approval is contingent on additional information being supplied to the European Medicines Agency that support the drug’s benefit-risk profile. To comply, the manufacturers, Regeneron and Sanofi, are adding a new patient group to EMPOWER-CSCC-1 to obtain additional data.

The FDA approved cemiplimab for patients with CSCC in September 2018.

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

This week, we sat down with Dr Anthony Mato, of Memorial Sloan Kettering Cancer Center, to discuss recent breakthroughs in the treatment of patients with refractory CLL.

That’s all for today.

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