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news.The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended three cancer drugs for approval.
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The CHMP adopted a positive opinion recommending approval of Pfizer's Ibrance (palbociclib) in combination with endocrine therapy to treat HR-positive, HER2-negative metastatic breast cancer.
Its opinion specifies that Ibrance be used either in combination with an aromatase inhibitor in the frontline setting, or combined with fulvestrant after progression on endocrine therapy.
In three separate randomized trials, the addition of Ibrance to standard endocrine therapy resulted in significant prolongation of progression-free survival compared to endocrine therapy alone.
Apart from Ibrance, the CHMP has issued a positive opinion recommending the granting of a conditional marketing authorization for Eli Lilly’s olaratumab, in combination with doxorubicin, to treat adults in the European Union (EU) with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin.
The CHMP reviewed olaratumab under EMA's accelerated assessment program. It is the first regulatory step in the world towards approval for olaratumab.
The EMA earlier granted olaratumab with orphan drug designation to treat soft tissue sarcoma in the EU.
It will be Lilly's initial conditional approval in the EU. As part of a conditional marketing authorization, Lilly will need to provide results from an ongoing Phase 3 Announce study, which is fully enrolled.
Additionally, the CHMP has adopted a positive opinion, recommending the conditional approval of Takeda Pharmaceutical’s Ninlaro (ixazomib) capsules in combination with lenalidomide and dexamethasone to treat adults with multiple myeloma who have received at least one prior therapy.
Data from the pivotal phase 3 study showed that the addition of Ninlaro to lenalidomide and dexamethasone offers a significant improvement in progression-free survival when compared to placebo plus lenalidomide and dexamethasone in this patient population.
Image: The European Medicines Agency's CHMP recommends three cancer drugs for approval. Photo: courtesy of jscreationzs at FreeDigitalPhotos.net.