From the FDA Oncological Advisory Committee

[Guest guest]

Hello All,

Not many people are aware that even after a drug makes it to market, the

drug companies must continue to provide data on the efficacy of the drugs in

the form of post marketing Phase IV trials.

Good reading!

Cheers,

Cheryl-Anne

Oncologic Committee To Meet Nov. 8 On Accelerated Approval Commitments

FDA will seek advice from its Oncologic Drugs Advisory Committee on how

sponsors can better execute studies to complete postmarketing commitments

for accelerated approval drugs.

The committee will meet Nov. 8 to " identify difficulties associated with

completion of Phase IV commitments " and provide " advice to sponsors to

assist in the planning and execution of postmarketing commitments of newly

approved drugs, " FDA said.

Office of Oncology Drugs Director Pazdur discussed the difficulties

in completing accelerated approval commitments at the Sept. 14 review of

GlaxoKline's Arranon and said there would be a meeting on the topic.

In its deliberations, the committee will review the status of Phase IV

commitments for & /Alza's Doxil, MedImmune's Ethyol,

Seragen's Ontak, SkyePharma's DepoCyt, Pfizer's Celebrex, Wyeth's Mylotarg

and Genzyme/Ilex' Campath.

The status of Phase IV commitments for all of the cancer agents, except

Campath, was previously reviewed by the committee in 2003.

One drug that was discussed at that meeting is not on the new meeting

agenda: Schering-Plough's Temodar. Schering is listed on FDA's postmarketing

commitments database as having fulfilled its commitment for Temodar

(temozolomide) in anaplastic astrocytoma.

J & J's commitment for Doxil (liposomal doxorubicin) in Kaposi's sarcoma is

listed by FDA as having been submitted.

The commitment for DepoCyt (liposomal cytarabine) in neoplastic and

lymphomatous meningitis is considered delayed; the study was initially

stalled by manufacturing problems experienced by the company in 1999-2000.

The commitments for Ethyol (amifostine) in cisplatin toxicity prevention,

Ontak (denileukin diftitox) in cutaneous T-cell lymphoma, Celebrex

(celecoxib) in adenomatous polyps, Mylotarg (gemituzumab) in acute myeloid

leukemia and Campath (alemtuzumab) in chronic lymphocytic leukemia are

described as ongoing.

The committee discussion could provide guidance to companies with ongoing or

delayed accelerated approval confirmatory trials for more recently approved

drugs.

Eight oncologics approved since 2002 have unfulfilled accelerated approval

commitments, according to FDA's postmarketing study database.

AstraZeneca's Arimidex and Genzyme's Clolar are the only products with

uninitiated confirmatory trials, according to the database. Biogen Idec's

confirmatory trial for Zevalin has been initiated, but is delayed.

AstraZeneca (Iressa), Bristol-Myers Squibb/Imclone (Erbitux), GSK (Bexxar),

Lilly (Alimta) and Novartis (Gleevec) have ongoing accelerated approval

studies.