Navigation Links
FDA grants Genentech's Perjeta® (pertuzumab) accelerated approval for use before surgery in people with HER2-positive early stage breast cancer
Date:10/1/2013

(September 30, 2013) The U.S. Food and Drug Administration (FDA) granted accelerated approval of a Perjeta (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER2-positive early stage breast cancer.

This approval is based primarily on data from a Phase II study showing that nearly 40 percent of people receiving the combination of Perjeta, Herceptin (trastuzumab) and docetaxel chemotherapy had no evidence of tumor tissue detectable at the time of surgery (known as a pathological complete response, or pCR). The most common severe (Grade 3 or higher) AEs for the Perjeta regimen were neutropenia (decrease in a certain type of white blood cell, 44.9 percent), febrile neutropenia (fever associated with decrease in a certain type of white blood cell, 8.4 percent), leukopenia (decrease in overall white blood cells, 4.7 percent) and diarrhea (5.6 percent).

This new neoadjuvant indication for Perjeta is for use prior to surgery in combination with Herceptin and docetaxel chemotherapy in people with HER2-positive, locally advanced, inflammatory, or early stage (tumor is greater than two centimeters in diameter or node positive) breast cancer. Perjeta should be used as part of a complete treatment regimen for early stage breast cancer. This use of Perjeta is based on an improvement in the percentage of people who had no evidence of cancer in the breast or lymph nodes at the time of surgery. Currently, no data have shown whether or not treatment with Perjeta prior to surgery improves survival. The safety of Perjeta as part of a doxorubicin (chemotherapy)-containing regimen has not been established. The safety of Perjeta administered for greater than six cycles for early stage breast cancer has not been established. Please see Perjeta full Prescribing Information including Most Serious Side Effects for additional Important Safety Information at http://www.perjeta.com.

Background on Neoadjuvant Treatment:

Upon receiving an early stage breast cancer diagnosis, a person typically undergoes surgery and may then receive a medicine in the "adjuvant" (post-surgery) setting. Neoadjuvant treatment is another treatment option given after diagnosis but before surgery. Neoadjuvant treatment may allow a doctor to quickly access whether a medicine is working, and may also reduce a tumor's size so it is easier to surgically remove.

WHY THIS APPROVAL IS IMPORTANT

  • Treating people with breast cancer early, before the cancer has spread, may offer the best chance of preventing the disease from returning.
  • The Perjeta regimen is the first treatment approved under a new FDA pathway for neoadjuvant use in breast cancer.
  • This new approval pathway makes Perjeta available to people with high-risk, early stage breast cancer more quickly than is possible with traditional approvals.
  • HER2-positive breast cancer is a particularly aggressive form of the disease that affects approximately 25 percent of people with breast cancer.


'/>"/>

Contact: Russell Grant
grantr@fleishman.com
212-453-2430
Fleishman-Hillard
Source:Eurekalert

Related medicine news :

1. Professors at Purchase College and Columbia University Receive More Than $500,000 in Grants to Study New Ways to Reduce Anxiety Disorders
2. Canon and Evergreen Help Thirty Community Groups Across Canada Plant Native Trees with $150,000 in Grants
3. Cashless Nigeria: Central Bank Of Nigeria Grants Globasure Approval to Operate as a Payment Terminal Service Provider (PTSP)
4. American Brain Tumor Association Seeks Inventive Ideas for Research Discovery Grants
5. 2 Georgia cancer patient support organizations to receive Survivor Circle grants from ASTRO
6. Life Sciences Discovery Fund announces $3.7m in research and development grants
7. Mount Sinai Grants Exclusive License to Plexcera Therapeutics to Develop Treatments for Farber Disease and Cystic Fibrosis
8. New NIH grants to investigate disease-related variations in genetic makeup
9. NIH grants Brown University $11M for brain research
10. ASTRO awards $34,500 in individual grants to top researchers presenting at the 2013 Annual Meeting
11. ASTRO to award $675,000 in junior faculty research grants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/9/2016)... ... December 09, 2016 , ... Sober College, ... with the grand opening of the Sober College Robert Pfeifer Memorial Learning Center ... December 2-3, and was attended by an overwhelming amount of alumni, family, colleagues ...
(Date:12/9/2016)... , ... December 09, 2016 , ... "I had a ... inventor from Winchester, Va. "I thought that if the nebulizer had a more child-friendly ... than fearing them." , He developed the patent-pending NEBY to avoid the need to ...
(Date:12/8/2016)... , ... December 08, 2016 , ... ... Franchising Company LLC, announced the first national #QuackGivesBack campaign which supported local ... “This was our first franchise-wide Quack Gives Back initiative, and we’re ...
(Date:12/8/2016)... ... December 08, 2016 , ... With the increasing demand for dental implants, the ... (WIYM) campaign to inform dentists and patients about the safety issues related to dental ... market in the U.S. is projected to reach $6.4 billion in 2018 with more ...
(Date:12/8/2016)... ... 2016 , ... Catalent Pharma Solutions, the leading global provider ... products, today announced that it had joined the Pharmaceutical Supply Chain Initiative (PSCI). ... unite pharmaceutical and healthcare companies that share a vision of better, social, environmental ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... , Dec. 8, 2016  Eli Lilly and ... results of its phase 3 EXPEDITION3 trial at the ... meeting. As previously disclosed, solanezumab did not meet the ... of solanezumab initiated in people with mild dementia due ... regulatory submissions for solanezumab for the treatment of mild ...
(Date:12/8/2016)... de dezembro de 2016  A Mederi Therapeutics Inc . anunciou aprovação ... não cirúrgico para a doença do refluxo gastroesofágico (DRGE). Foto -  ... ... Live Stretta procedure performed and broadcast during the Chinese ... Union Hospital , ...
(Date:12/8/2016)... Pa. , Dec. 8, 2016  Pennsylvania ... Secretary of Drug and Alcohol Programs Gary ... and insomnia medications, known as benzodiazepines, developed with ... "Benzodiazepines are medications that are frequently prescribed ... when they are used with opioid pain medications, ...
Breaking Medicine Technology: