The US FDA has approved a potential blockbuster drug with Cambridge roots to treat metatistic breast cancer, partners in the venture, AstraZeneca and Merck & Co, have revealed.
Business Weekly flagged up the potential in breast cancer for lynparza (olaparib) in early November in an interview with Cambridge dontrepreneur Professor Steve Jackson.
He told us: “Recently it has become clear that there is headroom for further cancer treatments harnessing Lynparza, other than ovarian cancer. The FDA recently fast-tracked its potential in the area of prostate cancer while its possible use to treat breast cancers also appears to be gaining pace.”
Lynparza promises to be the second blockbuster drug with Cambridge roots, following the success of Humira which stemmed from IP created at Cambridge Antibody Technology – acquired by AZ for around £567 million in May 2006.
Professor Jackson’s former company KuDOS Pharmaceutical gave birth to Lynparza. AstraZeneca paid £120 million for KuDOS in December 2005.
The new FDA approval for Lynparza is for use in patients with a certain type of metastatic breast cancer who have been previously treated with chemotherapy.
Under an oncology collaboration with Merck, announced in July 2017, AstraZeneca – which is building its new corporate HQ and research hub at Cambridge Biomedical Campus – is potentially eligible for more than $6 billion of future sustainable and ongoing externalisation revenue in the form of sales-related and approval-related payments plus option payments until 2019.
Following this new approval for Lynparza, AstraZeneca will receive $70 million in sustainable and ongoing externalisation revenue.
Dave Fredrickson, executive vice-president and head of the Oncology Business Unit at AstraZeneca, said: "This new approval for Lynparza makes it the first and only PARP inhibitor approved in metastatic breast cancer and the only PARP inhibitor approved beyond ovarian cancer.
“This is significant for breast cancer patients as the identification of BRCA status, in addition to hormone receptor and HER2 status, becomes a potentially critical step in the management of their disease.”
This is the third indication approved for Lynparza in the US, where it has been used to treat nearly 4,000 advanced ovarian cancer patients. Lynparza has the broadest clinical development programme of any PARP inhibitor and AstraZeneca and Merck are working together to deliver Lynparza as quickly as possible to more patients across multiple settings, including breast, ovarian, prostate and pancreatic cancers.
• Image courtesy – AstraZeneca