Pertuzumab received US FDA approval for the treatment of HER2-positive metastatic breast cancer later that year. Results of a Phase II trial in the neoadjuvant setting, NeoSphere, published in 2012, and results of a Phase II cardiac safety study in the same population, Tryphaena, published in 2013. The FDA approved the neoadjuvant indication in 2013. Pertuzumab was approved for medical use in the European Union in 2013. Society and culture
Economics
As of 2016, in the US each cycle of the three-drug combination given every three weeks costs around US$8,500, not including ancillary care costs.In the UK, a NICE evaluation in 2015, made a preliminary finding that the drug combination was not cost effective, and NICE rejected the drug in the neoadjuvant setting in May 2016, primarily because it was unknown if the drug combination provided a survival benefit. This decision was subsequently reversed six months later and pertuzumab became the first new breast cancer drug to be approved by NICE for routine NHS funding in almost a decade
after Roche pledged to provide the drug to the NHS at an undisclosed discount for patients in the neoadjuvant setting and to share the long–term financial risks. References
Further reading
Dean L (2015). "Pertuzumab Therapy and ERBB2 (HER2) Genotype". In Pratt VM, McLeod HL, Rubinstein WS,  et al. (eds.). Medical Genetics Summaries. National Center for Biotechnology Information (NCBI). PMID 28520364. Bookshelf ID: NBK315949. External links
"Pertuzumab". Drug Information Portal. U.S. National Library of Medicine.
Glossoptosis is a medical condition and abnormality which involves the downward displacement or retraction of the tongue. It may cause non-fusion of the hard palate, causing cleft palate. It is one of the features of Pierre Robin sequence and Down syndrome. == References ==