>>CHMP Adopts Negative Opinion on Genasense(R) Application in Melanoma
Friday April 27, 9:23 am ET
Genta to request re-examination and review by EMEA Oncology Scientific Advisory Group
Company will also file data quality complaint and correction request in U.S. regarding erroneous FDA analysis and presentation to ODAC of melanoma trial data
BERKELEY HEIGHTS, N.J., April 27 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that it has received notice from the European Medicines Agency (EMEA) that the Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for the Company's marketing authorization application (MAA) for Genasense® (oblimersen). The MAA proposes the use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The Company had previously announced its anticipation of this negative opinion on March 23, 2007.
According to the notice, Genta has been accorded the option of requesting re-examination of this opinion, and the Company intends to promptly file this request, which will delay any formal action by the EU Commission pending its outcome. Pursuant to the request, Genta expects to submit the "Detailed Grounds for Re-Examination" document within 60 days, and the Company will request review of the outstanding issues by the Oncology Scientific Advisory Group (OSAG).
"While this initial action was expected, we reaffirm our commitment to patients with advanced melanoma who have virtually no suitable treatment alternatives," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We believe the safety and efficacy results for Genasense plus dacarbazine are superior to any other product ever considered by regulatory authorities for advanced melanoma. During the re-examination, we look forward to discussion and resolution of outstanding issues with the OSAG, and we anticipate that a final opinion could be rendered by the EMEA within approximately 4 to 6 months. Meanwhile, we have announced the Company will commence a new randomized trial of the Genasense/dacarbazine combination, and we have made provisions for the supply of Genasense via compassionate use and named-patient distribution programs for patients who may not be protocol candidates."
In a separate action, Genta will file a formal complaint and request for correction of information with the U.S. Food and Drug Administration (FDA) under the Federal Data Quality Act. The complaint will challenge as erroneous a key statistical analysis of the Company's data on Genasense for melanoma used by FDA at the Oncology Drug Advisory Committee meeting on May 3, 2004. That analysis sought to discredit the finding that Genasense yielded a statistically significant increase in progression-free survival (PFS). At that meeting, ODAC voted unanimously that PFS was an endpoint that would support full approval in the absence of a survival improvement in patients with advanced melanoma. The Company will seek a formal public acknowledgement of the error, removal of the analysis from the FDA website (with a note that the previous analysis was in error), and revision of the transcript.
"We were unable to verify the integrity of this highly non-standard analysis in advance of the ODAC meeting," said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development. "Since then, we have been able to test the statistical model, and we show clearly that the analysis was erroneous. We are obviously concerned about the perpetuation of this error and its potential impact on public perception of our results, and we are formally requesting redress."<<
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So ODAC is being painted as the bad cop (I have heard Pazdur appointed people unfriendly and unfocused (i.e. breast cancer specialists for a melanoma review) to the ODAC that reviewed Genasense) -- as opposed to the CBER committee that reviewed Provenge, which would be the good cop. But now EMEA's OSAG also renders a negative vote. Did that committee also tweak the statistics to hurt Genasense? Was the FDA's statistical analysis done by the same gal that was so vocally opposed to Provenge, Dr. Hussain? I haven't looked, something for more interested parties/conspiracy theorists to check into.
Cheers, Tuck |
