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December 2015PDF

 

 Multiple Myeloma

Head-to-Head Phase III Study Demonstrates Kyprolis Nearly Doubles PFS over Velcade

Results from the phase III head-to-head ENDEAVOR study comparing Kyprolis to Velcade in patients with relapsed multiple myeloma showed that patients treated with Kyprolis achieved progression-free survival of 18.7 months compared to 9.4 months (HR=0.53; 95% CI: 0.44, 0.65; p<0.0001).

The findings demonstrated that patients treated with Kyprolis (carfilzomib) plus dexamethasone lived twice as long without disease worsening as those treated with Velcade (bortezomib) plus dexamethasone.

Also:

 Leukemia

AML Patients Receiving PKC412 Midostaurin Show 23% OS Improvement in Phase III Trial

Adult patients under 60 years of age with newly-diagnosed FLT3-mutated acute myeloid leukemia who received the investigational compound PKC412 (midostaurin), plus standard induction and consolidation chemotherapy, experienced a 23 percent improvement in overall survival (HR=0.77, p=0.0074), compared to those treated with standard induction and consolidation chemotherapy alone.

In the phase III RATIFY clinical trial, the median OS for patients in the PKC412 treatment group was 74.7 months (95% CI: 31.7, not attained), versus 25.6 months (95% CI: 18.6, 42.9) for patients in the placebo group.

The trial evaluated the addition of either PKC412 or placebo to daunorubicin/cytarabine in the induction phase, followed by high-dose cytarabine in the consolidation phase; patients who achieved complete remission after consolidation chemotherapy continued treatment with PKC412 or placebo as a single agent for up to one year.

 Drugs and Targets

FDA Approves Opdivo Injection for Renal Cell Carcinoma Patients

FDA approved Opdivo (nivolumab) injection for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.

In the CheckMate-025 trial, patients treated with Opdivo achieved a median OS of 25 months (95% CI: 21.7-not estimable) versus 19.6 months (95% CI: 17.6-23.1) for everolimus, a current standard of care (HR: 0.73; [95% CI: 0.60-0.89; p=0.0018]), based on a prespecified interim analysis. In the study, the safety profile was consistent with prior Opdivo studies.

Also:

Pancreatic Cancer

 Liver Metastases

Phase III Melphalan Trial Shows Improvement in Hepatic-PFS in Melanoma Patients

20151225 - Dec. 25, 2015
ISSUE 46 – DEC. 18, 2015PDF



How Medical Devices Do Harm

Friends call him The Hoomanator, a darkly comical conflation of his first name, Hooman, and morcellator, the medical device he has aggressively campaigned against.

Enemies—who are great in number—call him much worse.

Over the past two years, Hooman Noorchashm, a cardiac surgeon at Thomas Jefferson University Hospital, has been accused of launching a “campaign of distortions,” threatened with legal action, subjected to security searches and publicly chastised.

Over a two-year investigation, The Cancer Letter tracked Noorchashm and his wife, Amy Reed, as they challenged FDA, Congress, hospitals, the gynecology profession and manufacturers of medical devices. Their struggle began with a routine hysterectomy, during which a device called a power morcellator disseminated Reed’s undetected sarcoma. Today, as Amy’s aggressive disease spreads, the couple continues to draw public attention to the blind spots in the U.S. medical device regulatory system.

Two Docs Who Broke the Code

Hooman Noorchashm sends out several scathing emails each day.

Consider the subject lines of some recent emails that went to hospital administrators, with copies to members of Congress and the press: “Your ethical lapse and negligence.” “Outrageous!” “Your corruption.” “The Fouled Ethics of Your Specialty.” “Do read with care.”

“The time for diplomacy has passed,” Noorchashm said to The Cancer Letter. “I have no time to play politics. I have a wife with advanced cancer and six young children.”

His wife, Amy Reed, is battling advanced leiomyosarcoma. Since her undetected cancer was spread via power morcellation performed at Brigham & Women’s Hospital in October 2013, Reed has been in treatment for metastatic disease.

“Every time I see her go through these different phases and I think about the implications of it, it gives me a little bit more resolve to look at the root cause of this thing and hit it as hard as I can,” Noorchashm said.

The Root Causes of Harm From Medical Devices

The FDA Office of Criminal Investigations is being asked to determine why the agency has failed to detect the upstaging of cancers in women who had been operated on with a power morcellator.

These devices, widely used to shred uterine tissue in minimally invasive gynecological surgery, are now known to upstage undetected cancers that, according to FDA, occur in one of about 350 patients undergoing hysterectomies and myomectomies.

It took over two decades for the agency to realize that thousands of women may have died from metastatic uterine sarcoma upstaged by power morcellators, Rep. Mike Fitzpatrick (R-Pa.) wrote in a Dec. 18 letter to the agency.

Conversation with The Cancer Letter

Vodra: 510(k) Process Does Not Assess Risk; Needs to Be Broken Up Into Multiple Risk Groups

FDA’s Class II 510(k) clearance process for medium-risk devices—a category that includes the power morcellator—is inadequate, because it does not focus on risk assessment, according to Bill Vodra, a former associate chief counsel for drugs at FDA.

Instead, the 510(k) process relies on “substantial equivalence” to predicate devices, thereby allowing subsequent iterations of a device to introduce risk without active FDA surveillance.

“A huge variety of devices are now in Class II, and they pose extraordinarily different kinds of risk,” Vodra said. “The current test for clearance of a 510(k) is, ‘Is the proposed device substantially equivalent to another device (the predicate device or device chain) that has been marketed?’ “The answer may be yes, but that does not tell you much about risk of the proposed device or its predicates.”

Pilot: Don’t Change 510(k), Put More Money Into Enforcing Reporting Laws

Patients are being harmed because FDA doesn’t commit sufficient resources to enforce federal requirements for hospitals and manufacturers to report adverse outcomes caused by medical devices, according to Larry Pilot, one of the original authors of FDA’s 510(k) device clearance process.

There is no need to revamp the 510(k) process, Pilot said. The agency should instead enforce existing laws to make device manufacturers and user facilities report adverse outcomes.

“It’s a good system we have now, but FDA needs to allocate more resources to enforcement, especially for user facilities,” Pilot said. “That’s why FDA, with its authority, and this opportunity to put the emphasis on reporting to the user facility required by law, and then by specific regulation, should be going for money penalties for user facilities that do not abide by the reporting requirement.”

Daniel: FDA Does Not Have a Reliable Surveillance System for Medical Devices

Devices aren’t tracked with the same rigor as drugs, because FDA does not have a data system that can reliably track medical devices and identify potential safety problems, according to Gregory Daniel, fellow and managing director of the Center for Health Policy at Brookings Institution.

“Without having such a data system that can be used for active safety surveillance—i.e., safety monitoring that doesn’t rely on reporting of adverse events by providers or manufacturers—it is challenging to quickly identify potential safety issues with devices early on,” Daniel said.

Capitol Hill

Congress Passes $1.1 Trillion Omnibus Bill

Boosting NIH Budget by $2 Billion

Congress passed a $1.1 trillion government spending bill Friday morning, increasing the NIH budget by $2 billion. The measure now moves to the president’s desk for approval.

Editorial

The Year in Review

As the New Year approaches, we are preparing to revamp our website and launch an app. The work on it is almost done—a January launch seems likely.

In 2015, we got to report some cool stories, win national journalism awards and successfully deflect Amgen’s attack on our First Amendment rights.

In Brief

  • Raymond DuBois named dean of MUSC College of Medicine
  • John “Drew” Ridge elected medical staff president at Fox Chase – Temple Health
  • Bhramar Mukherjee appointed associate director for population science at University of Michigan Comprehensive Cancer Center
  • Joseph Smith Jr. awarded Huggins Medal from the Society of Urologic Oncology
  • Society of Toxicology honors award recipients, including Richard Adamson with the Founders Award
  • Albert Einstein Cancer Center awarded NIH grant
  • OHSU and Cancer Research UK to collaborate on early detection
  • St. Jude opens proton therapy center
  • IU Simon Cancer Center taking high school and college applicants for its Summer Research Program
  • HealthWell Foundation launches fund for underinsured multiple myeloma patients
Drugs and Targets

  • FDA approves Bendeka injection, a bendamustine formulation for infusion
  • Stem Cell Theranostics and CapellaBio launch collaboration on cardiotoxicity
  • Amgen enters into agreement with GSK to reclaim rights to Prolia, XGEVA, and Vectibix

 

The Cancer Letter will take a publishing break and return Jan. 8, 2016.

20151218 - Dec. 18, 2015
ISSUE 45 – DEC. 11, 2015PDF



Core Grants of Newer, Smaller Centers

Slated to Get Immediate Funding Boost

NCI is implementing a less draconian formula for increasing the core grants of newer cancer centers.

The plan, which was unveiled at the Dec. 1 joint meeting of the Board of Scientific Advisors and the National Cancer Advisory Board, seeks to correct an acknowledged inequity: by virtue of being in the NCI program longer, more established cancer centers had more incremental increases, thus amassing larger core grants.

In a unanimous vote, BSA asked for some refinements to the plan, but seemed to be fine with its main features.

An earlier version of the plan called for fundamental changes in the funding formula, which—according to NCI modeling—would have reduced the core grants of some of the older, larger cancer centers and gave these funds to the newer centers.

Capitol Hill

NIH Looks For $1-2 Billion Raise in FY 2016

As Congress Approaches Another Deadline

NIH is slated to receive a $2 billion increase under the Senate appropriations bill, but only $1.1 billion under the House plan for the current 2016 fiscal year.

The Senate version would bring NIH finding up to $32 billion, with NCI receiving $5.204 billion. The House version would total just above $31 billion for NIH, including $5.081 billion for NCI.

Both chambers of Congress are setting aside $200 million for the Precision Medicine Initiative, which would include $70 million for NCI.

Guest Editorial

The Academic Difference

By George J. Weiner

Academic cancer centers have a major and unique role to play in enhancing cancer research, clinical care and education. This role will increase in value as our understanding of the complexity of cancer grows and is applied to care of patients.

Academic cancer centers leverage synergies among these various missions, with the result being a positive impact on patient health and the economy at the local, regional and national levels. Accelerating progress in cancer medicine is dependent on the success of academic cancer centers and development of new models of collaboration between academic cancer centers and community oncology.

ACS and ASCO Jointly Publish Breast Cancer Survivorship Guideline for Primary Physicians

The American Society for Clinical Oncology and the American Cancer Society published a joint guideline for primary care physicians on managing the long-term care of breast cancer survivors, recommending regular surveillance for recurrence, but not performing laboratory or imaging tests in patients not displaying symptoms.

In Brief

  • Carlos Rodriguez-Galindo to lead St. Jude’s international outreach
  • Daniel Simon named president of UH Case Medical Center
  • Terrill Jordan named president and CEO of Regional Cancer Care Associates
  • Gustave Roussy institute recruiting young doctors
  • Baylor to collaborate with Biocept on blood-based cancer tests
Drugs and Targets

  • FDA grants accelerated approval to Alecensa for ALK-positive NSCLC patients
  • FDA approves Vistogard for emergency treatment of certain chemotherapy overdoses
  • FDA clears cooling cap for preventing hair loss during chemotherapy
  • EMA grants orphan designation ot Debio 1143
  • Amgen submits expanded application for Kyprolis in the EU
  • AstraZeneca and Voluntis to test digital support service in ovarian cancer trials
  • Eli Lilly and Merck to collaborate on abemaciclib-Keytruda phase I trial
20151211 - Dec. 11, 2015