Perjeta is the brand name for pertuzumab, a humanized monoclonal antibody used in HER2-positive breast cancer treatment. It is commonly used in combination with trastuzumab and chemotherapy in metastatic and early-stage settings. The FDA first approved Perjeta on June 8, 2012.
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
A JAMA Oncology study finds breast cancer patients using complementary and alternative medicine face a higher risk of death. A new molecule SU212 shows promise against triple-negative breast cancer, and global breast cancer cases are projected to rise to 3.5 million by 2050.
Exploratory analysis from a phase 1/2 trial shows CD47 expression levels predict response to evorpacept plus zanidatamab in heavily pretreated HER2-positive metastatic breast cancer patients, supporting biomarker-driven patient selection.
Former Novartis executive John Tsai has been appointed global head of R&D at Daiichi Sankyo, replacing Ken Takeshita effective April 1. Tsai brings over 25 years of leadership experience in drug development.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06884254 |
Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer. |
WITHDRAWN | PHASE3 |
| NCT05802225 |
Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05738993 |
A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers |
UNKNOWN | PHASE1 |
| NCT05323981 |
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection |
COMPLETED | PHASE1 |
| NCT03161353 |
Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy. |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT03058939 |
Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer |
WITHDRAWN | PHASE2 |
