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AZ plans Aust blood cancer debut
Posted 2 November 2017
AstraZeneca has confirmed Australian filing plans for its first haematology drug Calquence (acalabrutinib), which sped through the FDA winning approval in just two months.
"We are delighted that the FDA has granted accelerated approval for Calquence in the US, for adult patients with previously-treated mantle cell lymphoma (MCL)," an AstraZeneca Australia spokesperson said.
"We intend on working with authorities to make this treatment available to Australian patients as soon as we can."
Calquence was filed in the US in August with an expected decision date for 2018, but the regulatory body quickened the process by handing down a provisional approval just this week for the rare blood cancer indication.
Full approval will be conferred on the drug pending post-market confirmatory trials.
Though AZ has stayed quiet on exact Australian plans, its last FDA provisionally approved oncology drug Tagrisso (osimertinib) made its way onto the ARTG around nine months after its US designation was granted. Should Calquence follow the same timeline, it could be registered by the third quarter of 2018.
The drug is AZ's first major foray into the haematology market, hailed by CEO Pascal Soriot as a future "cornerstone" of their presence in the area and will expand the UK compan's current cancer portfolio of lung and ovarian/breast cancer therapies.
Its entry into the market will also bring competition for rival BTK inhibitor Imbruvica (ibrutinib), which was considered by the PBAC this week for reimbursement in relapsed or refractory merkel cell lymphoma after securing TGA approval in 2015.
Imbruvica has had a slow road to reimbursement in Australia, waiting almost three years for its December PBS-listing in chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL).
AZ acquired Calquence in 2015 after it bought a majority stake in Acerta Pharma for USD7 billion, eyeing a potential blockbuster future for the therapy. Apart from MCL, the company is conducting clinical trials in a number of other blood cancer indications including CLL, follicular lymphoma, multiple myeloma and diffuse large B-cell lymphoma.
Yajun Ma
yajun.ma@lushmedia.com.au
Posted 2 November 2017
AstraZeneca has confirmed Australian filing plans for its first haematology drug Calquence (acalabrutinib), which sped through the FDA winning approval in just two months.
"We are delighted that the FDA has granted accelerated approval for Calquence in the US, for adult patients with previously-treated mantle cell lymphoma (MCL)," an AstraZeneca Australia spokesperson said.
"We intend on working with authorities to make this treatment available to Australian patients as soon as we can."
Calquence was filed in the US in August with an expected decision date for 2018, but the regulatory body quickened the process by handing down a provisional approval just this week for the rare blood cancer indication.
Full approval will be conferred on the drug pending post-market confirmatory trials.
Though AZ has stayed quiet on exact Australian plans, its last FDA provisionally approved oncology drug Tagrisso (osimertinib) made its way onto the ARTG around nine months after its US designation was granted. Should Calquence follow the same timeline, it could be registered by the third quarter of 2018.
The drug is AZ's first major foray into the haematology market, hailed by CEO Pascal Soriot as a future "cornerstone" of their presence in the area and will expand the UK compan's current cancer portfolio of lung and ovarian/breast cancer therapies.
Its entry into the market will also bring competition for rival BTK inhibitor Imbruvica (ibrutinib), which was considered by the PBAC this week for reimbursement in relapsed or refractory merkel cell lymphoma after securing TGA approval in 2015.
Imbruvica has had a slow road to reimbursement in Australia, waiting almost three years for its December PBS-listing in chronic lymphocytic leukaemia (CLL) and small lymphocytic leukaemia (SLL).
AZ acquired Calquence in 2015 after it bought a majority stake in Acerta Pharma for USD7 billion, eyeing a potential blockbuster future for the therapy. Apart from MCL, the company is conducting clinical trials in a number of other blood cancer indications including CLL, follicular lymphoma, multiple myeloma and diffuse large B-cell lymphoma.
Yajun Ma
yajun.ma@lushmedia.com.au
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