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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation, jcm@btobioinnovation.com
“2017 Oncology Development Review” from Bruno Pagliari
Bruno Pagliara, principal of On-Kos Pharma Consulting in Milan, Italy, publishes regularly reviews on the status of worldwide oncology clinical portfolio. You will find herewith some of the highlights of his most recent report published in the January 2018 issue of MedNous. www.mednous.com
Approvals and line extensions
Oncology drug approvals accelerated in 2017, with a total of 18 new drugs approved during the year in either the EU, the US or Japan. The previous record was 14 new drugs in 2012. Novartis launched three of them. In addition, already marketed drugs received 37 new indications, in some cases, multiple indications for the same drug.
New mechanisms of action
Among the 18 new drugs approved, five have entirely new mechanism of action.
Two new “first in class” chimeric antigen receptor (CAR) T cell therapies, have been approved by the US FDA within a few weeks difference. Novartis’ Kymriah or tisagenlecleucel, for a 3rd line treatment of acute lymphoblastic leukemia, and Gilead’s (former Kite Pharma) KTEC19 for a 3rd line treatment of diffuse large B cell lymphoma.
Lutathera, a lutenium octreotide, a nuclear medicine from Advanced Accelerator Applications (AAA), another first of a kind, was approved in the US, for the treatment of gastroenteropancreatic neuroendocrine tumors. Shortly after the approval AAA, a France based company, was acquired by Novartis.
Immuno-oncology
The new immuno-oncology sector further expanded last year. Fifteen out of the 55 new drugs and new indications were checkpoint inhibitors. One of the success factor of this class of compounds is linked to its rapid onset and long-lasting effect. However, only a small minority of patients receiving the drug respond positively.
Regulatory
Amongst other novelties, it is worthwhile noting the rise, both in the EU and in the US, of oncology drug approvals based on single-arm studies.
The US FDA continues of being the regulator of choice for oncology submissions. In 2017, 14 out of the 18 new drugs received their first market authorization in the US and 28 of the 37 new indications were delivered by the US regulator.
32 drugs have received US FDA “breakthrough therapy designation” or European Priority Medicine (PRIME) status
Looking into 2018
According to Pagliara’s study, eight oncology drugs and 17 new indications, for already approved drugs, are currently under regulatory review. On 31 December 2017, the global oncology pipeline has reached a record high with eight new drugs in pre-registration, 133 in Phase 3 or registration trials, 267 in Phase 2 and 766 in Phase 1.
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