20.03.2014

Alternative treatment for metastatic cancer mean

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Pertuzumab was approved by FDA as a preoperative treatment regimen for early breast cancer patients. Pertuzumab, also known by its brand name as Perjeta, was already approved in combination with trastuzumab and docetaxel chemotherapy in HER2 positive metastatic breast cancer patients, who are not treated with any chemotherapy or HER2 therapy before.
According to this approval, Pertuzumab will be used along with Trastuzumab and chemotherapy in early, HER2 positive breast cancer patients before undergoing surgery as HR2 expresses a higher level of this protein which is involved in growth and survival of cancer.
The approval decision was granted under the FDA Accelerated Approval Program, an initiative which allows faster drug approvals in diseases with high level of unmet needs. Accelerated approvals are granted for drugs, which use surrogate endpoints in initial studies.  Surrogate endpoints are intermediate endpoints, which are indicative of the clinical benefit and are incorporated in studies to save time.
However, drugs approved under this program should be evaluated in confirmatory studies using actual endpoints of clinical benefit.


The accelerated approval of Pertuzumab was based on the results of Phase II, NEOSPHERE study. NEOSPHERE (NEOadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation study used pathological complete response (pCR) as a surrogate endpoint and investigated the efficacy of Pertuzumab regimen in neoadjuvant, HER2 positive breast cancer patients. Roche, the company which manufactures Pertuzumab, has also submitted additional supportive data from TRYPHAENA, a Phase II study investigating cardiac safety of Pertuzumab, in its supplementary new drug application (sNDA) to US FDA. Roche is also conducting a large, Phase III studies, APHINITY (Adjuvant Pertuzumab and Herceptin in INitial TherapY) with more than 4500 patients. Metastasis is the movement or spreading of cancer cells from one organ or tissue to another. This journal is a member of and subscribes to the principles of the Committee on Publication Ethics.
Failure to demonstrate the benefits in these studies, can lead to revocation of the approval status.


Overall, the Pertuzumab regimen demonstrated a significant (17.8 percent more) increase in pCR compared to the non-pertuzumab regimen. This study is designed to evaluate the disease-free survival (DFS) achieved by comparing Pertuzumab in combination with Trastuzumab and chemotherapy with Trastuzumab and chemotherapy.
The present accelerated approval will be converted to full approval upon review of the data from APHINITY.



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