FDA Backs Novel First-Line Treatment Pertuzumab for Early Stage Breast Cancer


FDA Approved PertuzumabThe FDA made a historic move on September 12, 2013 with their nod to approve Pertuzumab, a monoclonal antibody (mAb), as a pre-surgical treatment for patients with early-stage metastatic breast cancer. Pertuzumab is currently approved as a treatment for women with late-stage breast cancer, but it is administered after surgery has been completed. This new methodology of treating early-stage metastatic breast cancer before surgery is a courageous and exciting prospect for patients in early stages of this disease. When used as a first-line treatment Pertuzumab, known as the brand name Perjeta, has proven in clinical trials to be effective and tolerable.

As a novel pharmaceutical option, Pertuzumab is especially efficacious as it has shown in studies its ability to shrink and even eliminate tumors prior to surgical intervention. One such study, spearheaded by Genentech, the company who markets Perjeta, revealed overwhelmingly positive data in favor of Pertuzumab. Coined NEOSPHERE {Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation}, this multicenter and randomized international study proved to be quite enlightening. There were 417 patients enrolled in the NEOSPHERE study, all who were diagnosed with HER2-positive early-stage breast cancer. The participants all had locally advanced cases with tumors averaging two centimeters or more.  The patients were randomly assigned to one of four study arms, and each group received a total of four cycles of treatment of three weeks each. The participants in this study who received  a combination of Perjeta (Pertuzumab), Herceptin and Docetaxel had a pathological complete response rate (pCR) that was 58 percent better than the pCR for the patients who received only Herceptin and Docetaxel. The pCR rates for the participants in this study were uplifting, as data gleaned from NEOSPHERE showed a sharp decrease in tumor tissue detectable at the time of surgery.

Another study, named TRYPHAENA {ToleRabilitY of Pertuzumab, Herceptin and AnthracyclinEs in NeoAdjuvant breast cancer}, also offered encouraging data regarding the use of Pertuzumab. Results from this study proved the both the safety and tolerability of Pertuzumab in relation to adverse cardiac event risks. Results from TRYPHAENA offered reassurance to both patients and practitioners, as there were no new or unexpected cardiac adverse events observed in any of the study arms. Common side effects of Pertuzumab were diarrhea, nausea, exhaustion and hair loss. Severe adverse effects were uncommon. With HER2-positive breast cancer affecting roughly one quarter of the patients diagnosed, the advent of this neoadjuvant treatment is a pharmaceutical triumph. The American Cancer Society reports that in 2013 there will be 235,000 people diagnosed with breast cancer. This staggering number of diagnoses only offers more fuel as to the need for new and viable treatments for breast cancer.

LGM Pharma provides API Pertuzumab CAS# 380610-27-5 for research and development purposes. Clients can be assured of continuous support throughout the R&D process, as well as quality API products.

 

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e)+A13(1). Any patent infringement and resulting liability is solely at buyer risk.

  • Share: