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FDA Approvals of HPV Vaccine and NGS Assay, Priority Review in Myeloma, and More

Gina Columbus
Published: Monday, Oct 15, 2018



Today-

FDA approvals of an HPV vaccine and a next-generation sequencing assay, a priority review designation in multiple myeloma, and an ODAC recommendation for a biosimilar.

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

The FDA has approved the HPV vaccine Gardasil 9 for use in males and females aged 9 through 45 years.

Gardasil 9 has been shown to prevent cancers and other diseases caused by 9 types of HPV: 6, 11, 16, 18, 31, 33, 45, 52, and 58. The FDA initially approved Gardasil 9 in 2014 for use in males and females aged 9 through 26 years.

Gardasil, the predecessor to Gardasil 9, was approved by the FDA in 2006. Gardasil is no longer distributed in the United States; however, efficacy data for Gardasil can be extrapolated to Gardasil 9, since the 2 vaccines are similarly manufactured, and Gardasil targets 4 of the 9 HPV types covered by Gardasil 9.

In a large trial of women aged 27 to 45, Gardasil demonstrated an efficacy rate of 88% in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV 6, 11, 16, and 18. The study included approximately 3200 women with an average follow-up of 3.5 years.

The FDA used these data, as well as updated long-term follow-up data from the same study, as the basis for increasing the approved age up to 45 for Gardasil 9 in women.

The new approval of Gardasil 9 for men aged 27 to 45 was based on inferred efficacy from the 3200-women Gardasil trial and efficacy results for Gardasil in men aged 16 to 26. The agency also reviewed immunogenicity data from a study in which a 3-dose regimen of Gardasil over 6 months was assessed in men aged 27 to 45 years.

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The FDA has approved the next-generation sequencing assay clonoSEQ as a test for minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.

The in vitro diagnostic identifies and quantifies gene sequences in DNA extracted from the bone marrow of patients with ALL or multiple myeloma using multiplex polymerase chain reaction and NGS. The assay detects as few as 1 tumor cell within more than 1 million healthy cells.

Moreover, the clinical validity of clonoSEQ was seen in a retrospective analysis of samples collected from a clinical trial involving patients with ALL and 2 trials involving those with multiple myeloma.

Researchers in these trials used the assay to assess MRD at various disease burden thresholds and determined that MRD status correlated with event-free survival. EFS was longer and EFS rates were higher for patients assessed as MRD-negative. Results were similar for progression-free survival and disease-free survival among patients with multiple myeloma.

The agency reviewed clonoSEQ through the de novo premarket review pathway for new types of novel, low-to-moderate-risk devices. Additionally, the FDA established special controls clarifying expectations regarding the efficacy, accuracy, and reliability of tests using MRD to assess changes in disease burden during and following therapy.

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

In multiple myeloma, the FDA has granted a priority review to a new drug application for selinexor for the treatment of patients with penta-refractory disease. Selinexor links to and inhibits XPO1, which is a nuclear export protein.

The NDA is based on data from the phase IIb STORM trial, which evaluated the combination of selinexor and dexamethasone in patients with penta-refractory multiple myeloma. Updated findings from the study showed that the doublet regimen was associated with an overall response rate of 26.2% and a median overall survival of 8.6 months in patients with penta-refractory disease.

Overall, patients who had any response to treatment did significantly better, with a median OS of 15.6 months. Historically, the median OS in this patient population is an estimated 3.6 months.

The most common grade 3/4 treatment-related hematological adverse event was thrombocytopenia, followed by anemia, neutropenia, leukopenia, and lymphopenia. There was only 1 case of grade 4 anemia and no grade 4 leukopenias recorded.

Under the Prescription Drug User-Fee Act, the FDA is scheduled to decide on the NDA by April 6, 2019.

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

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 recommending approval of the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody’s non-Hodgkin lymphoma indications.

Should the FDA agree with the panel’s recommendations and grant approval to CT-P10, the biosimilar would be approved to treat adult patients with CD20-positive follicular lymphoma plus chemotherapy in the frontline setting, followed by single-agent maintenance in responders; as a monotherapy for relapsed/refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma; and as a single agent in patients with low-grade, CD20-positive, B-cell non-Hodgkin lymphoma who do not progress following first-line chemotherapy.

ODAC was tasked with determining whether the data submitted in a biologics license application by Celltrion and Teva Pharmaceutical Industries, the co-developers of CT-P10, demonstrated the biosimilarity between CT-P10 and rituximab in terms of efficacy, safety, pharmacology, analytical similarity, and immunogenicity.

The panel specifically considered findings from 2 randomized, double-blinded trials submitted with the BLA, both of which showed no clinically meaningful differences between CT-P10 and standard rituximab.

Beyond follicular lymphoma, rituximab has approved indications for diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

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

This week, we sat down with Dr Tanios Bekaii-Saab, of Mayo Clinic, to discuss later lines of therapy for metastatic colorectal cancer.

That’s all for today.

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

FDA approvals of an HPV vaccine and a next-generation sequencing assay, a priority review designation in multiple myeloma, and an ODAC recommendation for a biosimilar.

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

The FDA has approved the HPV vaccine Gardasil 9 for use in males and females aged 9 through 45 years.

Gardasil 9 has been shown to prevent cancers and other diseases caused by 9 types of HPV: 6, 11, 16, 18, 31, 33, 45, 52, and 58. The FDA initially approved Gardasil 9 in 2014 for use in males and females aged 9 through 26 years.

Gardasil, the predecessor to Gardasil 9, was approved by the FDA in 2006. Gardasil is no longer distributed in the United States; however, efficacy data for Gardasil can be extrapolated to Gardasil 9, since the 2 vaccines are similarly manufactured, and Gardasil targets 4 of the 9 HPV types covered by Gardasil 9.

In a large trial of women aged 27 to 45, Gardasil demonstrated an efficacy rate of 88% in preventing persistent infection, genital warts, vulvar and vaginal precancerous lesions, cervical precancerous lesions, and cervical cancer related to HPV 6, 11, 16, and 18. The study included approximately 3200 women with an average follow-up of 3.5 years.

The FDA used these data, as well as updated long-term follow-up data from the same study, as the basis for increasing the approved age up to 45 for Gardasil 9 in women.

The new approval of Gardasil 9 for men aged 27 to 45 was based on inferred efficacy from the 3200-women Gardasil trial and efficacy results for Gardasil in men aged 16 to 26. The agency also reviewed immunogenicity data from a study in which a 3-dose regimen of Gardasil over 6 months was assessed in men aged 27 to 45 years.

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

The FDA has approved the next-generation sequencing assay clonoSEQ as a test for minimal residual disease in patients with acute lymphoblastic leukemia or multiple myeloma.

The in vitro diagnostic identifies and quantifies gene sequences in DNA extracted from the bone marrow of patients with ALL or multiple myeloma using multiplex polymerase chain reaction and NGS. The assay detects as few as 1 tumor cell within more than 1 million healthy cells.

Moreover, the clinical validity of clonoSEQ was seen in a retrospective analysis of samples collected from a clinical trial involving patients with ALL and 2 trials involving those with multiple myeloma.

Researchers in these trials used the assay to assess MRD at various disease burden thresholds and determined that MRD status correlated with event-free survival. EFS was longer and EFS rates were higher for patients assessed as MRD-negative. Results were similar for progression-free survival and disease-free survival among patients with multiple myeloma.

The agency reviewed clonoSEQ through the de novo premarket review pathway for new types of novel, low-to-moderate-risk devices. Additionally, the FDA established special controls clarifying expectations regarding the efficacy, accuracy, and reliability of tests using MRD to assess changes in disease burden during and following therapy.

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

In multiple myeloma, the FDA has granted a priority review to a new drug application for selinexor for the treatment of patients with penta-refractory disease. Selinexor links to and inhibits XPO1, which is a nuclear export protein.

The NDA is based on data from the phase IIb STORM trial, which evaluated the combination of selinexor and dexamethasone in patients with penta-refractory multiple myeloma. Updated findings from the study showed that the doublet regimen was associated with an overall response rate of 26.2% and a median overall survival of 8.6 months in patients with penta-refractory disease.

Overall, patients who had any response to treatment did significantly better, with a median OS of 15.6 months. Historically, the median OS in this patient population is an estimated 3.6 months.

The most common grade 3/4 treatment-related hematological adverse event was thrombocytopenia, followed by anemia, neutropenia, leukopenia, and lymphopenia. There was only 1 case of grade 4 anemia and no grade 4 leukopenias recorded.

Under the Prescription Drug User-Fee Act, the FDA is scheduled to decide on the NDA by April 6, 2019.

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

The FDA’s Oncologic Drugs Advisory Committee voted 16-0 recommending approval of the rituximab biosimilar CT-P10 for 3 of the anti-CD20 monoclonal antibody’s non-Hodgkin lymphoma indications.

Should the FDA agree with the panel’s recommendations and grant approval to CT-P10, the biosimilar would be approved to treat adult patients with CD20-positive follicular lymphoma plus chemotherapy in the frontline setting, followed by single-agent maintenance in responders; as a monotherapy for relapsed/refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma; and as a single agent in patients with low-grade, CD20-positive, B-cell non-Hodgkin lymphoma who do not progress following first-line chemotherapy.

ODAC was tasked with determining whether the data submitted in a biologics license application by Celltrion and Teva Pharmaceutical Industries, the co-developers of CT-P10, demonstrated the biosimilarity between CT-P10 and rituximab in terms of efficacy, safety, pharmacology, analytical similarity, and immunogenicity.

The panel specifically considered findings from 2 randomized, double-blinded trials submitted with the BLA, both of which showed no clinically meaningful differences between CT-P10 and standard rituximab.

Beyond follicular lymphoma, rituximab has approved indications for diffuse large B-cell lymphoma and chronic lymphocytic leukemia.

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

This week, we sat down with Dr Tanios Bekaii-Saab, of Mayo Clinic, to discuss later lines of therapy for metastatic colorectal cancer.

That’s all for today.

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