Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

  • biotechnology industry,biotech company,clinical trials,Pfizer,Pipeline
  • fiercebiotech

Pfizer ($PFE) has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.

With the agency's designation, Pfizer is guaranteed access to top FDA officials as it develops inotuzumab ozogamicin as a treatment for acute lymphoblastic leukemia, a rare and deadly form of blood cancer. The breakthrough designation is tied to Phase III results disclosed earlier this year in which Pfizer's therapy met its goal of beating out standard care in spurring remissions for ALL patients.

Inotuzumab ozogamic is a so-called antibody-drug conjugate, hitching a cytotoxic compound to an antibody targeting the antigen CD22 and thus shuttling a cancer-killing substance straight to its malignant target. The FDA's breakthrough tag is designed to speed up the development of a treatments for unmet needs, and ALL, which affects about 6,000 Americans a year, carries a 5-year survival rate of less than 10%, Pfizer said.

The treatment's recent success is a welcome reversal for Pfizer and its oncology pipeline. The company had long heralded inotuzumab ozogamicin as a cornerstone of its ambitions in cancer therapy, but the case came apart in 2013 when the drug failed in a Phase III trial against non-Hodgkin's lymphoma, dimming analysts' expectations for its future in other diseases.

Now Pfizer is pressing forward with inotuzumab ozogamicin's Phase III ALL program. April's top-line success in remission rate was one of two primary endpoints. The second goal, overall survival, can't be measured until more patients in the study die. Pfizer plans to submit the results to regulators for approval once the study concludes.


This link:http://www.chemcd.com/news/19372.html

The ChemCD compiler finishing, shall not be reproduced without permission, for reprint please indicate the source。

comments powered by Disqus

Categories

Related News

Merck Announces FDA Acceptance of Biologics License Application for Bezlotoxumab, an Investigational Antitoxin for Prevention of Clostridium Difficile Infection Recurrence

Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for bezlotoxumab, an investigational antitoxin for prevention of Clostridium difficile (C. difficile) infection recurrence.

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.

First data backs efficacy of BMS' novel HIV drug

A Bristol-Myers Squibb (BMS) drug that causes immature HIV particles to be released from cells early, interrupting their lifecycle, has cleared a proof-of-concept study.

EU Rules Could Restrict Genetic Testing

Genetic testing describes the application of laboratory methods to look at a person’s genes (the inherited DNA instructions). Genetic tests can be used to diagnose a genetic condition; screen for a risk of developing a particular health problems; for the selection of treatments; or to assess responses to treatments.

CHMP adopts positive opinion of Edurant in adolescents with HIV-1

The CHMP has adopted a positive opinion recommending a change to the terms of the marketing authorisation for Janssen’s Edurant (rilpivirine) in the EU to extend the indication to adolescent patients aged 12 to <18 years with human immunodeficiency virus-1 (HIV-1) infection

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pfizer's once-failed cancer drug wins the FDA's 'breakthrough' tag

Pfizer has found new hope for a former pipeline standout, picking up the FDA's coveted breakthrough therapy designation for a Phase III reclamation project in oncology.