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FDA Approval in HCC, Priority Reviews in TNBC and Ovarian Cancer, sNDA in ITP, and More

Gina Columbus
Published: Monday, Nov 19, 2018



Today-

An FDA approval in hepatocellular carcinoma, priority review designations in triple-negative breast cancer and ovarian cancer, a supplemental new drug application in immune thrombocytopenia, and a biosimilar launched in the United States.

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

The FDA has granted pembrolizumab an accelerated approval for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.

The approval is based on data from the phase II KEYNOTE-224 trial, in which single-agent pembrolizumab induced an overall response rate of 17% among 104 patients with advanced HCC previously treated with sorafenib. Among the 18 patients who responded, there was 1 complete response and 17 partial responses. Moreover, 46 patients had stable disease, 34 patients had progressive disease, and 6 patients were not evaluable.

The median time to response was 2.1 months and, at the data cutoff, 12 of the 18 responses were ongoing and the median duration of response was not reached. Eighty-nine percent of the responders had a DOR greater than 6 months, and 56% had a DOR longer than 12 months.

Additionally, the median PFS was 4.9 months and the 12-month PFS rate was 28%. The median OS was 12.9 months and the 12-month OS rate was 54%.

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The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The application is based on the phase III IMpassion130 trial, in which the addition of the PD-L1 inhibitor to nab-paclitaxel reduced the risk of progression or death by 38% versus nab-paclitaxel alone in this patient population. Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the sBLA by March 12, 2019.

In the primary PFS analysis in the PD-L1–positive population, the median PFS was 7.5 months with atezolizumab/nab-paclitaxel and 5.0 months with chemotherapy. The 1-year PFS rates were 29% and 16% with atezolizumab/nab-paclitaxel and nab-paclitaxel, respectively.

At a 12.9-month follow-up, an interim OS analysis of the PD-L1–positive population showed a clinically meaningful improvement with added atezolizumab at 25.0 months versus nab-paclitaxel alone at 15.5 months.

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In ovarian cancer, the FDA has granted a priority review designation to a supplemental new drug application for olaparib tablets for use as a maintenance therapy in patients with newly diagnosed, BRCA-positive advanced disease who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

The application is based on findings from the phase III SOLO-1 trial, in which olaparib significantly improved progression-free survival as frontline maintenance for this patient population.

At a median follow-up of 41 months, the median PFS by independent central review was not reached with olaparib versus 14.1 months with placebo. The investigator-assessed PFS in the olaparib arm was not reached versus 13.8 months in the placebo arm. At 36 months, the PFS rate was 60% in the olaparib group versus 27% in the placebo arm.

The FDA action date for the application is set for the first quarter of 2019. Olaparib is currently FDA approved for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with 3 or more lines of chemotherapy.

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

The FDA has accepted a supplemental new drug application for review for avatrombopag as a treatment for patients with chronic immune thrombocytopenia who have had an inadequate response to prior treatment.

The application was based on results from the phase III Amendment 02 trial, which met its primary and first secondary efficacy endpoints, which were number of weeks with a specific platelet count greater than 50 x 109/L in the absence of rescue therapy and the proportion of patients with platelet counts greater than 50 × 109/L on day 8, respectively, with high statistical significance.



Data showed that avatrombopag was superior to placebo in the cumulative number of weeks of platelet response with a significantly longer duration of a platelet count ≥50 × 109/ L in the absence of rescue therapy versus placebo, with a median of 12.4 versus 0 weeks. Additionally, a greater platelet response rate was observed for patients who received avatrombopag at day 8 versus those who received placebo.

Under the Prescription Drug User Fee Act, the FDA will render a decision on the application by June 30, 2019.

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

Epoetin alfa-epbx, a biosimilar to epoetin alfa, has been launched in the United States at a significant discount. The shipment of the biosimilar to wholesalers throughout the United States began on November 12, 2018.

Prior to the launch announcement, the FDA approved the biosimilar in May 2018 to be used as a treatment for anemia caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV infection.

Epoetin alfa-epbx is also indicated for use prior to and following surgery to decrease the likelihood that patients will need a red blood cell transfusion due to blood loss from surgery.

The approval was based on data yielded from 2 single-center, randomized, open-label studies that demonstrated similarity between the biosimilar and epoetin alfa.

Epoetin alfa-epbx will now be introduced to the market at a substantial discount at a Wholesale Acquisition Cost of $11.03 per 1000 units/mL, which is 57.1% below the WAC of Procrit and 33.5% below the WAC of its reference product, Epogen.

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

This week, we sat down with Dr Johanna Bendell of Sarah Cannon Research Institute, to discuss the future management of metastatic colorectal 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 hepatocellular carcinoma, priority review designations in triple-negative breast cancer and ovarian cancer, a supplemental new drug application in immune thrombocytopenia, and a biosimilar launched in the United States.

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

The FDA has granted pembrolizumab an accelerated approval for the treatment of patients with hepatocellular carcinoma who have previously received sorafenib.

The approval is based on data from the phase II KEYNOTE-224 trial, in which single-agent pembrolizumab induced an overall response rate of 17% among 104 patients with advanced HCC previously treated with sorafenib. Among the 18 patients who responded, there was 1 complete response and 17 partial responses. Moreover, 46 patients had stable disease, 34 patients had progressive disease, and 6 patients were not evaluable.

The median time to response was 2.1 months and, at the data cutoff, 12 of the 18 responses were ongoing and the median duration of response was not reached. Eighty-nine percent of the responders had a DOR greater than 6 months, and 56% had a DOR longer than 12 months.

Additionally, the median PFS was 4.9 months and the 12-month PFS rate was 28%. The median OS was 12.9 months and the 12-month OS rate was 54%.

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

The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.

The application is based on the phase III IMpassion130 trial, in which the addition of the PD-L1 inhibitor to nab-paclitaxel reduced the risk of progression or death by 38% versus nab-paclitaxel alone in this patient population. Under the Prescription Drug User Fee Act, the FDA is scheduled to make its decision on the sBLA by March 12, 2019.

In the primary PFS analysis in the PD-L1–positive population, the median PFS was 7.5 months with atezolizumab/nab-paclitaxel and 5.0 months with chemotherapy. The 1-year PFS rates were 29% and 16% with atezolizumab/nab-paclitaxel and nab-paclitaxel, respectively.

At a 12.9-month follow-up, an interim OS analysis of the PD-L1–positive population showed a clinically meaningful improvement with added atezolizumab at 25.0 months versus nab-paclitaxel alone at 15.5 months.

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

In ovarian cancer, the FDA has granted a priority review designation to a supplemental new drug application for olaparib tablets for use as a maintenance therapy in patients with newly diagnosed, BRCA-positive advanced disease who achieved a complete or partial response to standard frontline platinum-based chemotherapy.

The application is based on findings from the phase III SOLO-1 trial, in which olaparib significantly improved progression-free survival as frontline maintenance for this patient population.

At a median follow-up of 41 months, the median PFS by independent central review was not reached with olaparib versus 14.1 months with placebo. The investigator-assessed PFS in the olaparib arm was not reached versus 13.8 months in the placebo arm. At 36 months, the PFS rate was 60% in the olaparib group versus 27% in the placebo arm.

The FDA action date for the application is set for the first quarter of 2019. Olaparib is currently FDA approved for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with 3 or more lines of chemotherapy.

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

The FDA has accepted a supplemental new drug application for review for avatrombopag as a treatment for patients with chronic immune thrombocytopenia who have had an inadequate response to prior treatment.

The application was based on results from the phase III Amendment 02 trial, which met its primary and first secondary efficacy endpoints, which were number of weeks with a specific platelet count greater than 50 x 109/L in the absence of rescue therapy and the proportion of patients with platelet counts greater than 50 × 109/L on day 8, respectively, with high statistical significance.



Data showed that avatrombopag was superior to placebo in the cumulative number of weeks of platelet response with a significantly longer duration of a platelet count ≥50 × 109/ L in the absence of rescue therapy versus placebo, with a median of 12.4 versus 0 weeks. Additionally, a greater platelet response rate was observed for patients who received avatrombopag at day 8 versus those who received placebo.

Under the Prescription Drug User Fee Act, the FDA will render a decision on the application by June 30, 2019.

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

Epoetin alfa-epbx, a biosimilar to epoetin alfa, has been launched in the United States at a significant discount. The shipment of the biosimilar to wholesalers throughout the United States began on November 12, 2018.

Prior to the launch announcement, the FDA approved the biosimilar in May 2018 to be used as a treatment for anemia caused by chronic kidney disease, chemotherapy, or the use of zidovudine in patients with HIV infection.

Epoetin alfa-epbx is also indicated for use prior to and following surgery to decrease the likelihood that patients will need a red blood cell transfusion due to blood loss from surgery.

The approval was based on data yielded from 2 single-center, randomized, open-label studies that demonstrated similarity between the biosimilar and epoetin alfa.

Epoetin alfa-epbx will now be introduced to the market at a substantial discount at a Wholesale Acquisition Cost of $11.03 per 1000 units/mL, which is 57.1% below the WAC of Procrit and 33.5% below the WAC of its reference product, Epogen.

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

This week, we sat down with Dr Johanna Bendell of Sarah Cannon Research Institute, to discuss the future management of metastatic colorectal cancer.

That’s all for today.

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