U.S. FDA Gives Rare Pediatric Disease Designation to AbbVie for Investigational ABT-414 for the Treatment of a Type of Pediatric Brain Tumor

July 11, 2016

AbbVie, a global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease Designation for ABT-414, an investigational antibody drug conjugate (ADC) that targets the epidermal growth factor receptor (EGFR) for the treatment of pediatric patients with EGFR-amplified Diffuse Intrinsic Pontine Glioma (DIPG). This is recognized as the highly aggressive and difficult to treat brain tumors found at the base of the brain.

Brainstem tumors are extremely rare among adults. However, they comprise approximately 10-15 percent of all pediatric brain tumors. DIPG is the most common subtype of tumor in this anatomical region and also the second most common malignant brain tumor of childhood. An estimated 200-400 children are affected each year in the United States with this sort of disease.

According to Gary Gordon, M.D., vice president, oncology clinical development, AbbVie: “Pediatric patients with high grade gliomas have a rare and fatal disease.2 This Rare Pediatric Designation, a first for AbbVie, is an important advancement as we continue to evaluate ABT-414 and its potential to help this group of patients who desperately need a new treatment option. The proposal of including a nested cohort within an adult global trial is an endeavor that we hope may bring more treatments to pediatric patients.”

 

CHMP Recommends EU Approval for Roche’s Avastin in Combination with Tarceva for Treating Advanced Lung Cancer

29 April, 2016

Roche has announced that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for treating adult patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. The most common type of lung cancer is NSCLC, which is the major cause of cancer-related death in Europe and across the world. Nearly 10-15 percent of Europeans with NSCLC have tumors with EGFR-activating mutations, which represents an estimated 33,000 cases in Europe per year, or 90 every day.

“Patients with EGFR mutated lung cancer who were treated with the combination of Avastin plus Tarceva lived significantly longer without their disease progressing compared to patients treated with Tarceva alone. We are delighted that this strategy of combining targeted medicines has improved patient outcomes. Today’s CHMP opinion brings us one step closer to providing this combination therapy option to patients,” said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development.

Avastin and Tarceva each target pathways which are known as key drivers in the development and growth of tumors. Results of other clinical studies also support the beneficial effect of Avastin plus which proves that the combination is effective and tolerable.