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Pipeline Monitor
Gilead scores first win from Kite buyout
Posted 20 October 2017
Gilead's Yescarta (axicabtagene ciloleucel) has been granted FDA approval for third-line treatment of relapsed or refractory large B-cell lymphoma after the pharma company paid USD12 billion for its sponsor biotech Kite Pharma.
Yescarta has become the second CAR-T approved in the US but will be the first treatment available for adults after Novartis' Kymriah (tisagenlecleucel) won approval for paediatric treatment of acute lymphoblastic leukaemia last month.
The new class of cancer therapies have been tagged as potentially revolutionary as they manipulate patients' own T-cells, creating personalised immune attacks on cancer tumours. According to Gilead's company statement, manufacturing turnaround of the specialised therapies takes a median of 17 days to complete.
Approval was granted based on data from the pivotal ZUMA-1 trial which demonstrated 72 per cent of patients experienced an objective response rate to Yescarta while 51 per cent demonstrated complete remission.
CHMP recommends six extensions
The latest CHMP meeting considered no new drugs for approval but six existing therapies were given recommendations to have their indications extended.
Three cancer drugs received recommendations for additional indications including Roche's Alecensa (alectinib) for an expanded first-line usage in ALK-positive advanced non-small cell lung cancer (NSCLC) while Janssen's Zytiga (abiraterone) was recommended to treat newly diagnosed high-risk metastatic hormone sensitive prostate cancer.
AZ's Faslodex (fulvestrant) also won positive opinion as a second-line therapy for HR- HER+ locally advanced or metastatic breast cancer in addition to its existing HR+ only indication.
Two drugs were given CHMP positive opinion on paediatric extensions: MSD's Cubicin (daptomycin) which was recommended for use in children aged one and older for treatment of complicated skin and soft-tissue infections, and Roche's Pegasys (peginterferon alfa-2a) recommended to treat children three years and older with negative-chronic hepatitis B.
AZ's Bydureon (exenatide) was also given CHMP recommendation for combination use with insulin to treat type 2 diabetes.
FDA hands out speedy reviews to cancer drugs
Three cancer therapies were granted speedy review designations by the FDA this week, putting them on track to get decisions on approval by next April.
AZ's Imfinzi (durvalumab) received priority review designation from the regulatory body for treatment of locally advanced unresectable NSCLC. The drug has been approved already in the US for bladder cancer under an accelerated approval designation.
BMS' checkpoint inhibitor Opdivo (nivolumab) also won speedy review for an additional high-risk resected melanoma indication while AZ and MSD's Lynparza (olaparib) was granted the priority tag for second-line use in germline BRCA-mutated, HER2- metastatic breast cancer.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 20 October 2017
Gilead's Yescarta (axicabtagene ciloleucel) has been granted FDA approval for third-line treatment of relapsed or refractory large B-cell lymphoma after the pharma company paid USD12 billion for its sponsor biotech Kite Pharma.
Yescarta has become the second CAR-T approved in the US but will be the first treatment available for adults after Novartis' Kymriah (tisagenlecleucel) won approval for paediatric treatment of acute lymphoblastic leukaemia last month.
The new class of cancer therapies have been tagged as potentially revolutionary as they manipulate patients' own T-cells, creating personalised immune attacks on cancer tumours. According to Gilead's company statement, manufacturing turnaround of the specialised therapies takes a median of 17 days to complete.
Approval was granted based on data from the pivotal ZUMA-1 trial which demonstrated 72 per cent of patients experienced an objective response rate to Yescarta while 51 per cent demonstrated complete remission.
CHMP recommends six extensions
The latest CHMP meeting considered no new drugs for approval but six existing therapies were given recommendations to have their indications extended.
Three cancer drugs received recommendations for additional indications including Roche's Alecensa (alectinib) for an expanded first-line usage in ALK-positive advanced non-small cell lung cancer (NSCLC) while Janssen's Zytiga (abiraterone) was recommended to treat newly diagnosed high-risk metastatic hormone sensitive prostate cancer.
AZ's Faslodex (fulvestrant) also won positive opinion as a second-line therapy for HR- HER+ locally advanced or metastatic breast cancer in addition to its existing HR+ only indication.
Two drugs were given CHMP positive opinion on paediatric extensions: MSD's Cubicin (daptomycin) which was recommended for use in children aged one and older for treatment of complicated skin and soft-tissue infections, and Roche's Pegasys (peginterferon alfa-2a) recommended to treat children three years and older with negative-chronic hepatitis B.
AZ's Bydureon (exenatide) was also given CHMP recommendation for combination use with insulin to treat type 2 diabetes.
FDA hands out speedy reviews to cancer drugs
Three cancer therapies were granted speedy review designations by the FDA this week, putting them on track to get decisions on approval by next April.
AZ's Imfinzi (durvalumab) received priority review designation from the regulatory body for treatment of locally advanced unresectable NSCLC. The drug has been approved already in the US for bladder cancer under an accelerated approval designation.
BMS' checkpoint inhibitor Opdivo (nivolumab) also won speedy review for an additional high-risk resected melanoma indication while AZ and MSD's Lynparza (olaparib) was granted the priority tag for second-line use in germline BRCA-mutated, HER2- metastatic breast cancer.
Yajun Ma
yajun.ma@lushmedia.com.au
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