Friday, December 19, 2014 5:19:05 PM
AstraZeneca just got an early approval (PhII) based on PFS:
Quote:
___________________________________________________
The FDA's approval is based on Phase II data in which the drug charted a 34% objective response rate for an average of 7.9 months. Treatment with olaparib also led to progression-free survival (PFS) of 11.2 months versus 4.3 months on placebo.
Those same results weren't enough to convince a panel of FDA advisers over the summer. In June, the agency's cancer drug committee picked apart olaparib's potential, taking issue with its failure to significantly improve overall survival, pointing to a few alarming adverse events and expressing doubts in the reliability of its PFS data. The group voted 11-2 against recommending an early approval for the drug, asking the agency to wait out AstraZeneca's ongoing Phase III study on olaparib before green-lighting it.
But AstraZeneca came back with additional information supporting the drug's use in thrice-failed patients who carry BRCA mutations, the FDA said, which was apparently enough to sway the agency's oncology division, affirming cancer chief Richard Pazdur's penchant for hurrying along new treatments that could change the standard of care.
_____________________________________________________________
LINK:http://www.fiercebiotech.com/story/astrazeneca-grabs-surprise-early-approval-its-2b-cancer-contender/2014-12-19?utm_medium=nl&utm_source=internal
"The refusal of the real is the number one dogma of our time" Rene Girard
Recent CDMO News
- Avid Bioservices to Participate at Upcoming Investor Conferences • GlobeNewswire Inc. • 05/07/2024 08:05:11 PM
- Avid Bioservices Reports Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 04/24/2024 09:25:33 PM
- Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q • GlobeNewswire Inc. • 03/20/2024 11:00:10 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/07/2024 11:30:11 AM
- Avid Bioservices Announces Pricing of Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/07/2024 04:58:48 AM
- Avid Bioservices Announces Proposed Private Placement of Convertible Notes • GlobeNewswire Inc. • 03/06/2024 09:32:07 PM
- Avid Bioservices Announces Certain Preliminary Financial Results for Third Quarter Ended January 31, 2024 • GlobeNewswire Inc. • 03/06/2024 09:31:28 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/06/2024 09:30:18 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/26/2024 09:57:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/13/2024 12:34:35 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:39:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:38:30 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:37:38 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:36:27 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/12/2024 12:35:47 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/11/2024 12:56:02 AM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 01/08/2024 09:32:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:56:18 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:55:07 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:53:58 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/04/2024 12:51:57 AM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 12/19/2023 09:05:52 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:34:08 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/19/2023 12:33:03 AM
FEATURED Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • May 8, 2024 9:05 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • BLOZF • May 7, 2024 8:51 AM