Are Cancer Drugs Getting Better? FDA’s Richard Pazdur Says, “Yes”
A meeting of the FDA Oncologic Drugs Advisory Committee has become a rare occurrence.
Why?
Because cancer drugs are getting better, as are applications for their approval, said Richard Pazdur, director of the FDA Office of Hematology and Oncology Products.
“Drug development is much more focused, and decisions are being made on the basis of understanding the molecular basis of the disease rather than the number of responses observed in an early phase study,” Pazdur said.
Partnership Points to New Path Forward For Drug Approval and Clinical Research
SWOG earlier this week started to accrue patients to Lung-MAP, a clinical trial for second-line treatment of non-small cell lung cancer.
The trial, also called Lung Cancer Master Protocol or SWOG S1400, uses the patients’ tumor characteristics to select one of five targeted therapies, comparing them with active control in each arm.
Lung-MAP is funded by a public-private partnership, which combines NCI’s limited funds with those of commercial sponsors, pointing to a new way of pooling resources to conduct faster, more efficient registration trials.
Genentech Move Nixes Hospital Discounts
Avastin, Herceptin, Rituxan Now Sold Under Tighter Control by Drug Maker
A move by Genentech has eliminated discounts and rebates hospitals receive when they purchase three of the company’s top-selling infused cancer drugs.
Beginning Oct. 1, hospitals can now order Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab) exclusively from six specialty distributors authorized by the drug maker.
Genentech said the move will bypass more than 80 full-line wholesale drug distribution centers, with the objective of enhancing efficiency and security of the supply chain for these widely used medications.
“Wild West” of Molecular Testing?
Caris Engaged in Aggressive Marketing, Improper Medicare Billing, Lawsuit Alleges
It’s possible that molecular testing is doing a lot of good, pinpointing cancer therapies that are most likely (or least likely) to work.
It’s also possible that Medicare is paying for molecular tests that are marketed aggressively despite being based on flimsy evidence.
The latter picture is painted in a suit filed by two former employees of Caris Life Sciences Inc., a company that markets the “Caris Molecular Intelligence” test, a panel of assays previously called “Target Now.”
UT System (Again) Directs DePinho To Cure MD Anderson Faculty Angst
Over the past two years, four separate surveys attempted to gauge the level of faculty morale and satisfaction at MD Anderson Cancer Center.
All produced similar results: faculty morale is low, and a large proportion of the faculty says the administration is tone-deaf to their needs. The executive leadership is seen as not appropriately responding to internal issues.
The latest survey—conducted by the UT System and reported on Nov. 3—allows comparison with the earlier efforts.
Top NCI Officials Pledge No Further Consolidation of Clinical Trials System
Top NCI officials made an unusual assurance that the reorganization of clinical trials cooperative groups isn’t a “prelude to reducing the commitment of the NCI to clinical trials-based research.”
The document, published as a letter to the editor of the Journal of Clinical Oncology on Dec. 1, follows up on a meeting Sept. 23, where group chairs and directors of statistical centers asked NCI to assure them that no new cuts are in the works.
How Elite Institutions Were Affected By A Decade of Constricted Funding
The ten-year period of erosion that followed the doubling of the NIH budget has hit some research institutions harder than others.
NIH appropriations figures provide a glimpse of the state of science funding in the U.S., but they don’t shed light on how individual institutions and areas of research are affected.
To conduct an exploratory analysis of levels of funding at specific institutions, The Cancer Letter compiled NIH and NCI funding figures from 2003 to 2013 for eight freestanding cancer centers and nine other research institutions that include cancer centers. A focus on freestanding cancer centers provides a snapshot of funding at institutions engaged primarily in basic and clinical cancer research.
Secretive Contract Manufacturing Arrangements Complicate Solutions to Shortages of Generics
It takes a few clicks to look up the name of a company that holds the “Abbreviated New Drug Application,” or ANDA, to make a generic drug. Alas, this information is of little value.
If you want to prepare for a drug shortage or pick a high-quality manufacturer to supply drugs, you need to know about the role of a contract manufacturer, the company that makes the drug. Currently, there is simply no way for the doctors or the public to get this information.
Even FDA can’t easily determine whether a drug is made by the ANDA sponsor or a contract manufacturer.
Judge’s Order Likely to Derail Federal Rule Clarifying 340B Drug Discount Program
Many people love the 340B Drug Pricing Program.
Hospitals, clinics and cancer centers rely on it to buy drugs at discounts as deep as 50 percent—and then collect reimbursements that don’t reflect the discount.
Many others hate 340B, arguing that the federal program gives qualified providers an unfair advantage, and making it even more difficult for office-based oncology practices to survive.
CMS Inserts Unprecedented Conditions Into Medicare Coverage of Lung Screening
CT screening of the lungs of current and former heavy smokers is about to become a Medicare benefit.
A proposed decision published Nov. 10 has inserted some unprecedented conditions into its decision to cover screening:
Beneficiaries would have to go through counseling, and health professionals would be required to provide documentation that “shared decision-making” took place. The Centers for Medicare and Medicaid Services has never mandated shared decision-making as a gateway to paying for a service.
Urgent FDA Action Turns Power Morcellation Into Rarely Used Gynecological Procedure
The power morcellator should no longer be used for hysterectomies or fibroid removal in the vast majority of women getting these procedures, FDA declared in a highly anticipated guidance document Nov. 24.
Using a new authority that bypasses public comment, the agency stopped short of imposing an outright ban on the device, but severely restricted its use in the following manner:
- The agency placed a “black box” label on the device, warning that the use of power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients. The boxed warning is FDA’s sternest warning for significant risk of serious or life-threatening adverse effects.
- The agency’s guidance decreed that power morcellators are contraindicated for removal of uterine tissue in menopausal and post-menopausal women, and in women who are eligible for surgeries that remove uterine tissue intact i.e. through the vagina or mini-laparotor.
- Similarly, power morcellators are now contraindicated in gynecologic surgery in which the tissue to be morcellated is known or suspected to be cancerous.
