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FDA Approval in MCL, sBLA Accepted in Ovarian Cancer, sBLA Submitted in DLBCL, and More

Gina Columbus
Published Online: Monday, Nov 06, 2017



Today-

An FDA approval in mantle cell lymphoma, a supplemental biologics license application accepted in ovarian cancer, an sBLA submitted in diffuse large B-cell lymphoma, and an acquisition by Novartis.

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

In mantle cell lymphoma, the FDA has granted an accelerated approval to acalabrutinib as a treatment for adult patients following at least 1 prior therapy.

The decision was based on results from the ACE-LY-004 phase II trial, in which the investigator assessed objective response rate was 81% with acalabrutinib, known by the trade name Calquence. Also in the trial, the complete response rate with acalabrutinib was 40% and the partial response rate was 41%.

This approval for the novel BTK inhibitor arrived several months ahead of expectations under the Prescription Drug User Fee Act and followed a breakthrough therapy designation from the FDA for MCL in early August 2017.

In the ACE-LY-004 study, 124 patients with MCL received oral acalabrutinib at 100 mg twice daily. At a median follow-up of 15.2 months, the objective response rate by independent review committee was 80%, which was comprised evenly of complete and partial response rates of 40%. The median duration of response was not yet reached at the time of analysis, with responses ongoing at more than 20 months. The median time to best response was 1.9 months.

Moreover, the most common adverse events of any grade were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. The most common grade 3 or higher adverse events were neutropenia, thrombocytopenia, anemia, and diarrhea.

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The FDA has accepted a supplemental biologics license application for bevacizumab for the first-line treatment of advanced ovarian cancer.

If approved, the new indication would make frontline bevacizumab available in combination with carboplatin and paclitaxel, followed by bevacizumab alone, for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The application is based on findings from the pivotal, multicenter, randomized, double-blind, placebo-controlled phase III GOG-0218 trial.

In the study, women with treatment-naïve stage III/IV ovarian cancer were randomly assigned to chemotherapy alone with AUC 6 carboplatin and 175 mg per square meter of paclitaxel, bevacizumab-initiation from cycle 2 through 7, or bevacizumab combined with chemotherapy followed by bevacizumab alone starting at cycle 2 and continuing throughout the study. Bevacizumab was administered at 15 mg/kg every 3 weeks.

Women assigned to the bevacizumab-continuation group for a total duration of 22 cycles had a median progression-free survival of 18.2 months versus 12.0 months in women who received chemotherapy alone.

Genentech, the manufacturer of bevacizumab, said adverse events in the trial were consistent with those seen in previous bevacizumab studies.

The FDA is expected to make a decision on the application by June 25, 2018.

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In diffuse large B-cell lymphoma, a supplemental biologics license application was filed with the FDA to expand the indication for tisagenlecleucel to include adults with relapsed/refractory disease who are ineligible for autologous stem cell transplant.

The FDA granted a breakthrough therapy designation for the chimeric antigen receptor T-cell therapy in this population in April 2017. Tisagenlecleucel was initially approved by the FDA in August 2017 for the treatment of children and adults up to age 25 with B-cell precursor acute lymphoblastic leukemia, which made it the first CAR T-cell therapy approved for use in the United States.

The sBLA is based on results from the global, multicenter, phase II JULIET study, in which tisagenlecleucel was associated with an objective response rate of 59% in 51 patients with DLBCL at a median follow-up of 3.7 months.

Forty-three percent of patients had a complete response and 16% achieved a partial response. Moreover, 79% of patients who demonstrated a complete or partial response at 3 months remained relapse free at 6 months. The median duration of response was not reached. Approximately one-quarter of patients experienced disease progression.

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Novartis announced a planned 3.9-billion dollar acquisition of Advanced Accelerator Applications, or AAA, which is a radiopharmaceutical company that develops, produces, and commercializes Molecular Nuclear Medicines.

AAA manufactures Lutathera, which is a first-in-class RadioLigand Therapy product for neuroendocrine tumors.

The European Union approved Lutathera for the treatment of unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors in September. In addition to Lutathera, the company has also developed the companion diagnostics NETSPOT and SomaKit TOC.

AAA’s board of directors has already approved a memorandum of understanding stating that Novartis will make a cash offer of $41 per ordinary share of AAA and $82 per American Depositary Share, each representing 2 ordinary shares, subject to certain conditions. This offer values the company at $3.9 billion.

Novartis plans to fund the deal through external short- and long-term debt.

The FDA is currently reviewing a new drug application for Lutathera for patients with gastroenteropancreatic neuroendocrine tumors. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision by January 26, 2018.

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

This week, we sat down with Dr Leena Gandhi of NYU Langone’s Perlmutter Cancer Center, to discuss the emerging role of alectinib in ALK-positive 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-

An FDA approval in mantle cell lymphoma, a supplemental biologics license application accepted in ovarian cancer, an sBLA submitted in diffuse large B-cell lymphoma, and an acquisition by Novartis.

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

In mantle cell lymphoma, the FDA has granted an accelerated approval to acalabrutinib as a treatment for adult patients following at least 1 prior therapy.

The decision was based on results from the ACE-LY-004 phase II trial, in which the investigator assessed objective response rate was 81% with acalabrutinib, known by the trade name Calquence. Also in the trial, the complete response rate with acalabrutinib was 40% and the partial response rate was 41%.

This approval for the novel BTK inhibitor arrived several months ahead of expectations under the Prescription Drug User Fee Act and followed a breakthrough therapy designation from the FDA for MCL in early August 2017.

In the ACE-LY-004 study, 124 patients with MCL received oral acalabrutinib at 100 mg twice daily. At a median follow-up of 15.2 months, the objective response rate by independent review committee was 80%, which was comprised evenly of complete and partial response rates of 40%. The median duration of response was not yet reached at the time of analysis, with responses ongoing at more than 20 months. The median time to best response was 1.9 months.

Moreover, the most common adverse events of any grade were anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising. The most common grade 3 or higher adverse events were neutropenia, thrombocytopenia, anemia, and diarrhea.

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

The FDA has accepted a supplemental biologics license application for bevacizumab for the first-line treatment of advanced ovarian cancer.

If approved, the new indication would make frontline bevacizumab available in combination with carboplatin and paclitaxel, followed by bevacizumab alone, for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

The application is based on findings from the pivotal, multicenter, randomized, double-blind, placebo-controlled phase III GOG-0218 trial.

In the study, women with treatment-naïve stage III/IV ovarian cancer were randomly assigned to chemotherapy alone with AUC 6 carboplatin and 175 mg per square meter of paclitaxel, bevacizumab-initiation from cycle 2 through 7, or bevacizumab combined with chemotherapy followed by bevacizumab alone starting at cycle 2 and continuing throughout the study. Bevacizumab was administered at 15 mg/kg every 3 weeks.

Women assigned to the bevacizumab-continuation group for a total duration of 22 cycles had a median progression-free survival of 18.2 months versus 12.0 months in women who received chemotherapy alone.

Genentech, the manufacturer of bevacizumab, said adverse events in the trial were consistent with those seen in previous bevacizumab studies.

The FDA is expected to make a decision on the application by June 25, 2018.

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

In diffuse large B-cell lymphoma, a supplemental biologics license application was filed with the FDA to expand the indication for tisagenlecleucel to include adults with relapsed/refractory disease who are ineligible for autologous stem cell transplant.

The FDA granted a breakthrough therapy designation for the chimeric antigen receptor T-cell therapy in this population in April 2017. Tisagenlecleucel was initially approved by the FDA in August 2017 for the treatment of children and adults up to age 25 with B-cell precursor acute lymphoblastic leukemia, which made it the first CAR T-cell therapy approved for use in the United States.

The sBLA is based on results from the global, multicenter, phase II JULIET study, in which tisagenlecleucel was associated with an objective response rate of 59% in 51 patients with DLBCL at a median follow-up of 3.7 months.

Forty-three percent of patients had a complete response and 16% achieved a partial response. Moreover, 79% of patients who demonstrated a complete or partial response at 3 months remained relapse free at 6 months. The median duration of response was not reached. Approximately one-quarter of patients experienced disease progression.

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

Novartis announced a planned 3.9-billion dollar acquisition of Advanced Accelerator Applications, or AAA, which is a radiopharmaceutical company that develops, produces, and commercializes Molecular Nuclear Medicines.

AAA manufactures Lutathera, which is a first-in-class RadioLigand Therapy product for neuroendocrine tumors.

The European Union approved Lutathera for the treatment of unresectable or metastatic, progressive, well differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors in September. In addition to Lutathera, the company has also developed the companion diagnostics NETSPOT and SomaKit TOC.

AAA’s board of directors has already approved a memorandum of understanding stating that Novartis will make a cash offer of $41 per ordinary share of AAA and $82 per American Depositary Share, each representing 2 ordinary shares, subject to certain conditions. This offer values the company at $3.9 billion.

Novartis plans to fund the deal through external short- and long-term debt.

The FDA is currently reviewing a new drug application for Lutathera for patients with gastroenteropancreatic neuroendocrine tumors. Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision by January 26, 2018.

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

This week, we sat down with Dr Leena Gandhi of NYU Langone’s Perlmutter Cancer Center, to discuss the emerging role of alectinib in ALK-positive 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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