Page 33 - InsideOut Magazine

treatment options, have remained cancer free for extended periods after CAR T-cell therapy. Patient success stories include children and adults whose leukemia returned for a third time — which many con- sider to be the fatal reoccurrence number — and were successfully put in remission due to CAR T-cell therapy. Many ALL patients also receive bone marrow transplanta- tion to ensure complete recovery.4
Novartis CTL019 is the first CAR T-cell therapeutic to receive break- through designation from the FDA for ALL and is currently in Phase II trials.1
Although some researchers and physicians are calling CAR T-cell therapy a pathway to the cure, this cancer immunotherapy poses dan- gerous side effects, including cytokine-release syndrome. The syndrome results from CAR T-cells releasing a rapid and massive amount of cytokine into the bloodstream, which can lead to dangerously high fevers and drops in blood pressure.
If a physician cannot manage the patient’s fever, the CAR T-cell therapy treatment must end. Most patients experienced mild side effects, how- ever, and were reported to respond to standard supportive therapies, such as steroids.3
Other Hallmark Approvals
New IV Antibiotics
Antibiotic resistance has been a concern for many healthcare profes- sionals, facilities and U.S. regulators. In fact, the FDA considers antibiotic resistance a threat to U.S. national security and public safety.
A strategy to address these concerns, called the Combating Antibiotic Resistant Bacteria (CARB) Strategy, was announced by the FDA in September 2014. The FDA, however, had actually begun approving new IV antibiotic drugs in May 2014. By late December 2014, the FDA had approved four: dalbavancin (Dalvance TM from Actavis/Durata Therapeutics) in May; tedizolid phosphate (Sivextro ® from Cubist Pharmaceuticals) in June; oritavancin (Orbactiv TM from The Medicines Company) in August; and ceftolozane/tazobactam (ZerbaxaTM from Cubist Pharmaceuticals) in December.
The FDA approved Dalvance, Sivextro and Orbactiv to treat acute bacterial skin and skin structure infections caused by bacteria such
as Staphylococcus aureus, includ- ing the methicillin-resistant strains known as MRSA infections. 5 Zerbaxa received FDA approval to treat adults with complicated intraabdominal infections and complicated urinary tract infections. 6
Each drug’s manufacturer was able to take advantage of recently
enacted incentives to help bring new antimicrobials to the public. Incentives include designation as a qualified infectious disease product (QIDP), which expedites the FDA application processes. QIDP also qualifies the drugs for five years of marketing exclusivity to be added
to the certain exclusivity already provided by the FDA. The FDA has granted QIDP designation to 39 anti- biotics that were under development in September 2014.
CARB is one aspect of the Generating Antibiotics Incentives Now (GAIN) Act, to promote development of antibacterial and antifungal drugs in theU.S.5
Refining Blood Safety
On December 19, 2014, the FDA ap- proved the Intercept Blood System, the first pathogen reduction system used to treat single donor apheresis platelets.
The system is a medical device — used by blood establishments — that collects and manufactures blood and blood components to prepare patho- gen reduced platelets for transfusion, and can be used on whole blood and apheresis donations. Inactivation of certain potential pathogens is achieved through a photochemical process that involves a controlled exposure to ultraviolet light and amotosalen, a chemical that facilitates the inactiva-
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Antibiotic resistance is a threat to U.S. national security and public safety.
— FDA