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Following outstanding features of palbociclib with regard to both efficacy and quality of life which has made it a blockbuster molecule in US and Europe with total 80,000 patients in just one year
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Palbociclib has got approval in FIRST LINE SETTING in metastatic breast cancer in post menapausal as first initial endocrine therapy with latrozole. It can be used directly in de novo new patients of first line metastatic breast cancer irrespective of any therapy used in adjuvant setting.
First molecule in history of oncology wherein PFS has come more in phase 3 (PALOMA 2) study of 25 months recently announced in asco 2016 compared to phase 2 PALOMA 1 study of 20.1 months which is double to that of aromatase inhibitors of 10 months.
This efficacy was seen across all subgroups which included patients of older age,patients with both lobular and ductal carcinoma and irrespective of adjuvant therapy.
50% patients in phase 3 study had visceral disease with clinical benefit rate of 76%.even those patients who had received chemotherapy or hormonal therapy in adjuvant setting had received the consistent benefit with palbo plus latrozole.
The most safe drug as only 6% patients had grade 3 and grade 4 NON FEBRILE neutropenia and this non febrile neutropenia was not like chemotherapy induced neutropenia. Here only 6% grade 3 neutropenia was cytostatic and not cytotoxic like chemotherapy . No GCSF was required at all as during one week off period neutrophils came to normal count automatically without any need of GCSF. all other side effects like fatigue and alopecia were of grade 1 and 2 and reversible with no loss of hair.
Net cost per month is only rs 76000 with lifetime free after 10 cycles. Considering that PFS is 24.8months as compared to 10 months and lifetime free after 10cycles net cost per month is rs 38000.
Apart from approval in first line metastatic breast cancer in post menopausal as initial endocrine therapy it also has got additional approval only in US in second Line setting in combination with faslodex.