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FDA to Review Trial Data in Real Time for Kadcyla Expanded Indication Study

February 11, 2019

The FDA will review Roche’s breast cancer drug Kadcyla (Trastuzumab emtansine) under its Real-Time Oncology Review and Assessment Aid pilot program, the drugmaker confirmed last week.

Kadcyla will be Roche’s first reviewed under the FDA’s Real-Time Oncology pathway, in which the agency can assess trial data as soon as it is generated rather than waiting until a drugmaker submits its formal application. The agency has approved four drugs under the real-time review pilot since July 2018.

The drug is currently indicated for treatment of previously treated HER2+ metastatic breast cancer, but Roche recently applied to expand its indication to HER2-positive early breast cancer patients who don’t fully respond to drug therapy before surgery.

Roche CEO Bill Anderson said in a January conference call that, between the real-time review and the agency’s breakthrough therapy designation, the company hopes to secure an FDA decision in the first quarter of 2019.

In December, the company presented data from its Phase III trial comparing Kadcyla to Herceptin, the company’s earlier breast cancer drug, in 1,500 patients and found that Kadcyla reduced risks of death or recurrence in early-stage patients with residual disease by 50 percent compared to Herceptin. Kadcyla had cut the risk of recurrence by 11 percent three years after treatment, according to Roche.

WCG Partners with Prudentia Group
WCG Clinical is partnering with drug safety and pharmacovigilance consulting firm Prudentia Group, the companies have announced.

Prudentia, headquartered in India, will work with WCG subsidiary Vigilare. Company officials hope the partnership will add “critical elements that will make our solution more powerful for clients, helping them make better, faster decisions with a greater degree of confidence,” WCG CEO Don Deieso said in a news release.

FDA Clarifies Efficacy Trials for Anti-Opioid Treatment
Sponsors that can provide specific data based on existing products won’t have to conduct new efficacy trials for the anti-opioid treatment buprenorphine injections or implants, says a new final guidance issued last week.

The FDA says it wants to clarify expectations for improving and speeding up other anti-opioid delivery mechanisms by specifying what kind of data can help bypass the efficacy stage, including:

  • The proposed drug/device’s pharmacokinetic profile;
  • The length of time a given treatment takes to reach a blood-plasma level that will block opioid reception;
  • The maximum and minimum plasma concentration;
  • The drug’s accumulation after several doses; and
  • An estimate of how long a drug will take to clear a patient’s system.

Read the guidance here: https://bit.ly/2F3Dmzo.

FDA Issues Recommendations for Eosinophilic Esophagitis Drug Trials
The FDA has released draft guidance on clinical trial designs for treatment of eosinophilic esophagitis (EoE), including recommendations for selecting trial participants.

Randomized, double-blind, placebo-controlled trials should include a pre-specified screening period before patients are randomized to confirm their eligibility, the guidance says. Trials should evaluate a drug’s effect on both symptoms and the underlying inflammation of the disease by assessing the coprimary endpoints in Phase III trials.

Following the initial efficacy assessment, the FDA strongly recommends a randomized withdrawal design to assess the incidence of relapse, the need for redosing and persistence of the drug’s effects.

The trial population should include patients with a history of mild to moderate esophageal strictures because they may be responsive to treatment. Patients with a history of severe strictures requiring dilation, strictures preventing passage of a standard, diagnostic upper endoscope, or any critical esophageal stricture that requires dilation at screening should be excluded, as they’re unlikely to respond to drug therapy.

Read the draft guidance here: https://bit.ly/2Bozt9e.

Informed Consent Doesn’t Equal Data Privacy Waiver, European Board Warns
Clinical trials operating in the EU need more clarity on data privacy and informed consent requirements, Europe’s top privacy regulator says.

In a document issued late last month, the European Data Protection Board (EDPB) says that a guidance on the impact of the EU’s new General Data Protection Regulation (GDPR) on clinical trials doesn’t go far enough in explaining more restrictive rules for informed consent.

EDPB’s opinion is in response to a request from the European Commission to evaluate the EU’s new Clinical Trials Regulation — set to take effect in 2020 — in light of the GDPR’s requirements.

The board recommends EU drug regulators revise their recently published guidance document, “Questions and Answers on the Interplay Between the Clinical Trials Regulation and the General Data Protection Regulation,” to more clearly define the legal basis for using personal data under GDPR and explain the types of data usage allowed in clinical trials with or without subjects’ explicit informed consent.

Sites, researchers and sponsors should be able to collect and use patients’ data in a trial, the board says, if they can demonstrate that the data usage is “carried out in the public interest” or “purely for research purposes.”

Read the board’s opinion here: https://bit.ly/2SwlTtW.