CANCELLED MORNING SESSION; AFTERNOON SESSION TO TAKE PLACE FROM 9 AM-3PM. July 24, 2012: Oncologic Drugs Advisory Committee Meeting Announcement

UPDATED INFORMATION (as of 7/13/12):
The morning session of the Oncologic Drugs Advisory Committee meeting that was to discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline for the proposed indication in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s) has been CANCELLED.

The afternoon session of the Oncologic Drugs Advisory Committee to discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies will take place from 9 a.m. to 3 p.m. on July 24, 2012.

In summary, the following updates are being made for the July 24, 2012 Oncologic Drugs Advisory Committee meeting:

Time
The time is updated to read: “9 a.m. to 3 p.m.”

Agenda:
The agenda is updated to read as follows: On July 24, 2012, from 9 a.m. to 3 p.m., the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.

Public Participation Information:
The sentence “Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 4:30 p.m. to 5 p.m. on July 24, 2012.” is updated to read “Oral presentations from the public will be scheduled between approximately 12:30 p.m. to 1:30 p.m. on July 24, 2012.”.

PREVIOUSLY UPDATED INFORMATION (as of 6/29/12)
The end time for the July 24, 2012 Oncologic Drugs Advisory Committee (ODAC) meeting has been extended to 6:00 p.m. The Procedure portion is changed to reflect an updated open public hearing time, from approximately 10:30 a.m. to 11 a.m. and 4:30 p.m. to 5:00 p.m. There are no other changes.

Time
The time should be updated to read: “8:00 a.m. to 6:00 p.m.”

Public Participation Information:
The sentence “Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. on July 24, 2012” should be updated to read “Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 4:30 p.m. to 5 p.m. on July 24, 2012”.

ORIGINAL INFORMATION

Agenda

During the morning session, the committee will discuss supplemental new drug application (sNDA) 022059/014 with the trade name Tykerb (lapatinib) tablets, application submitted by SmithKline Beecham (Cork) Ltd, Ireland d/b/a GlaxoSmithKline. The proposed indication (use) for this product is in combination with trastuzumab for the treatment of patients with metastatic breast cancer whose tumors overexpress HER2 and who have received prior trastuzumab therapy(s).

During the afternoon session, the committee will discuss the evaluation of radiographic review in randomized clinical trials using progression-free survival (PFS) as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a pre-specified subgroup of patients instead of an independent review of all progression assessments. The expectation is that an independent audit would streamline the conduct of clinical trials, as well as avoid missing data when no additional protocol specified progression assessments are mandated. Hematologic malignancies are excluded from this discussion because other issues (e.g., blood counts, lymph node exams, and other biomarkers) influence the assessment of PFS.

Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Background Material:

2012 Meeting Materials, Oncologic Drugs Advisory Committee

• Written submissions may be made to the contact person on or before July 10, 2012.
• Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. on July 24, 2012. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before June 29, 2012.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 2, 2012.

Webcast Information

CDER plans to provide a free of charge, live webcast of the July 24, 2012, meeting of the Oncologic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2012 Meeting Materials, Oncologic Drugs Advisory Committee.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

• Caleb Briggs, Pharm.D.
  Center for Drug Evaluation and Research
  Food and Drug Administration
  10903 New Hampshire Avenue
  WO31-2417
  Silver Spring, MD 20993-0002
  Phone: 301-796-9001
  Fax: 301-847-8533
  E-mail: ODAC@fda.hhs.gov

• FDA Advisory Committee Information Line
  1-800-741-8138
  (301-443-0572 in the Washington DC area)
  Please call the Information Line for up-to-date information on this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at (301) 796-9001 at least 7 days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: Public Meetings at the White Oak Campus.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).