ASCO 6/2011-a look at the oncology pipelines by the drug manufacturers
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Thank you Percy and Marion for this. Lets hope that the drugs that you mention come through the trials successfully and will be of help in fighting CC. I read an abstract from ASCO this year about Gleevec with regards to GIST.
Thank you both.
Gavin
I may add: Orphan drug status (we are an orphan cancer) equals fast track.
All other drugs have to establish efficacy within two years from date of original proposal. Missing it by one day only will result in final rejection by the FDA thus resulting in permanent dismissal of proposed study.
Before a drug comes to the market it undergoes numerous steps including a review boards. It can be kicked back for any reasons all the while the time clock continues to tick.
The safety standards for approval of drugs set by the FDI are strict and difficult to overcome. But, they present itself as one of the most powerful force in preserving patient safety.
All my best,
MarionHi,Gavin,
As you may know,phase 1 clinical trial is for drug safety.Phase 2 is for effectiveness.Phase 3 is for more safety,effectiveness,dosage determination and use in combination with other drugs.
Normally drug company can submit a new drug application (NDA)at the end of the phase 2 .FDA has 60 days to reply to decide whether to file it so that it can be reviewed.FDA can refuse to file an application if it is incomplete.
One of the quickest drug for approval is AZT for AIDS-approved in 108 days in 1987.
Gleevec( a molecularly targeted agent for cancer) is also a drug received accelerated approval in 2001 for CML in about 60 days.The approval was based on the results of three phase 2 studies.(not phase 3)
But even the drug is on”fast track” in general,it may still take between 6month to 2years after phase 2 to get approval and FDA can withdraw the approval anytime if they find serous problems.
God bless.Hi Percy,
Many thanks for this. Do you have any idea as to how long it would take for a drug to go from Phase 2 through to being an option for use for patients? Assuming of course that the drug in question was succesful throughout all of it’s trials etc. I hope that you manged to get some rest and get your energy levels up!
Best wishes,
Gavin
Hi,
Here are the oncology pipelines that are AT LEAST in Phase2 or higher in development by the drug manufacturers and may be of value to CC.1.Sorafenib(a tyrosine kinase inhibitor)-phase 4 for hepatocellular carcinoma (HCC) and phase 3 for NSCLC lung carcinoma by ONYX Pharmaceuticals.
2.Tivantinib(c-met pathway agent)-phase 3 in NSCLC & phase 2 in HCC. ;Tigatuzumab(in DR5 pathway)-phase 2 in HCC ; Efatutazone(in PPAR pathway) -phase 2 for colorectal and NSCLC by Daiichi-Sankyo.
3.Zibotentan (Phase 3);AZD8931(antiproliferation agent);selumetinib(MEK1/2 inhibitor);olaparib(a PARP inhibitor);cediranib-( a VEGFR inhibitor );MEDI-575 an anti-PDGFR monoclonal antibody by AstraZeneca.
4.Linifanib(phase 3) for HCC-an oral inhibitor of VEGF and PDGF receptor Nabitoclax and Veliparib-an oral PARP inhibitor by Abbott Laboratories.
3.Thrombopoietin receptor agonist(to treat low platelets count);multikinase inhibitor targeting MET, and VEGFR(for HCC);MEK1/2 inhibitor for pancreatic cancer ; angiogenesis inhibitors targeting VEGFR ,PDGFR ,and c-kit(phase 3) for renal cell carcinoma and ovarian ca by GlaxoSmithKline.
5.BIBF 1120( an oral angiogensis inhibitor for NSCLC lung and ovarian ca(both are in phase 3 trials) and phase 2 for HCC;Afatinib(an oral EGFR inhibitor for NSCLC-phase 3)Volasertib(a cell cycle kinase inhibitor targeting Plk pathway for lung and ovarian ca. by Boehringer Ingelheim.
I believe if the drugs are listed in phase 2 ,most if not all of them are at the end of phase 2 trial by the way the drug companies presented their product pipelines.
There were a few other companies I did not visit because of running out of time and energy.
God bless.
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