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MSD chases Keytruda combo in Aust
Posted 12 May 2017
MSD says that it will seek both approval and PBS listing for a combined Keytruda (pembrolizumab) and chemotherapy treatment in Australia for lung cancer.
"[MSD] will pursue the registration and reimbursement of Keytruda for first-line non-small cell lung cancer in combination with chemotherapy in Australia," a spokesperson for the company told Pharma in Focus.
The TGA has already approved the blockbuster's use as a monotherapy in both first- and second-line treatment of NSCLC, however the PD-1 inhibitor is yet to be PBS listed for either setting. The PBAC rejected the drug for second- and third-line use last year, while the first-line setting was shut down in the committee's most recent meeting.
However, a combination use with Lilly's chemo drug Alimta (pemetrexed) and carboplatin may mean better reimbursement chances for the drug, especially as its long-time cancer rival, BMS' Opdivo (nivolumab), nabbed a positive PBAC recommendation for second-line treatment in NSCLC at the same time Keytruda was rejected.
The company's confirmation of a double submission to the TGA and PBS also suggests that it will attempt to get the combo therapy through using parallel processing, which may reduce the treatment's time in the regulatory process.
In the US the treatment received accelerated approval for the indication just this week, making it an early entrant into the market for combination therapies involving star blockbusters,which are now increasingly on the horizon. Keytruda on its own has paired up with a number of partner drugs, including Array's MEK inhibitor binimetinib, Eisai's Halaven(eribulin), and Syndax's entinostat.
The combination drug submission was based on a clinical study that showed a reduction in death and disease progression among patients who were treated with the three-drug regimen.
The combination was also filed in the EU recently, with the CHMP's draft agenda showing it was due to come up in the next meeting on recommendations for drug extensions.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 12 May 2017
MSD says that it will seek both approval and PBS listing for a combined Keytruda (pembrolizumab) and chemotherapy treatment in Australia for lung cancer.
"[MSD] will pursue the registration and reimbursement of Keytruda for first-line non-small cell lung cancer in combination with chemotherapy in Australia," a spokesperson for the company told Pharma in Focus.
The TGA has already approved the blockbuster's use as a monotherapy in both first- and second-line treatment of NSCLC, however the PD-1 inhibitor is yet to be PBS listed for either setting. The PBAC rejected the drug for second- and third-line use last year, while the first-line setting was shut down in the committee's most recent meeting.
However, a combination use with Lilly's chemo drug Alimta (pemetrexed) and carboplatin may mean better reimbursement chances for the drug, especially as its long-time cancer rival, BMS' Opdivo (nivolumab), nabbed a positive PBAC recommendation for second-line treatment in NSCLC at the same time Keytruda was rejected.
The company's confirmation of a double submission to the TGA and PBS also suggests that it will attempt to get the combo therapy through using parallel processing, which may reduce the treatment's time in the regulatory process.
In the US the treatment received accelerated approval for the indication just this week, making it an early entrant into the market for combination therapies involving star blockbusters,which are now increasingly on the horizon. Keytruda on its own has paired up with a number of partner drugs, including Array's MEK inhibitor binimetinib, Eisai's Halaven(eribulin), and Syndax's entinostat.
The combination drug submission was based on a clinical study that showed a reduction in death and disease progression among patients who were treated with the three-drug regimen.
The combination was also filed in the EU recently, with the CHMP's draft agenda showing it was due to come up in the next meeting on recommendations for drug extensions.
Yajun Ma
yajun.ma@lushmedia.com.au
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