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Cancer Drug Shortages: Who's Minding the Store?

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Cancer Drug Shortages: Who's Minding the Store? ✽ ✽ [ News ✽ Analysis ✽ Commentary ✽ Controversy ] February 25, 2011 Vol. 33 No. 4 oncology-times.com Publishing for O33 Years NCOLOGY The Independent TIMES Hem/Onc News Source Cancer Drug Shortages: Who’s Minding the Store? he recent shortages of certain chemotherapy agents and other key drugs raise Tquestions about who’s in charge of the national drug supply and how to ensure availability when there are limited fi nancial incentives and no mandates that manu- facturers notify the FDA about upcoming shortages. Here’s what experts are saying. Page 25 iStockphoto.com/klenova ASCO: For Patients with Advanced Cancer, Start Frank Talks about Options Soon after Diagnosis p.22 iStockphoto.com ODAC Backs FDA on Post-Marketing Medical Home Concept Comes Studies for Accelerated-Approval to Oncology p.45 Drugs p.8 [ ALSO ] SHOP TALK . 4 JOE SIMONE: The Self-Referral Boom . .15 MIKKAEL SEKERES: On (cology) Language . .16 Colorectal Cancer: Best to Start Chemo by 4 Weeks After Surgery . 18 Breast Cancer: 4 Cycles of Adjuvant Chemo Usually Suffi cient . 36 WENDY HARPHAM: ‘It’s OK’. 40 POETRY BY CANCER CAREGIVERS . 47 Ph+ ALL: Early Use of Imatinib Extends Long-Term Survival. 49 Twitter.com/OncologyTimes PERIODICALS bitly.com/oncologytimes 9 oncology times Saturating Liver Cancers with Chemotherapy Found to Extend Survival & Decrease Toxicity athing liver tumors in chemo- The study included 93 patients: said Charles Nutting, DO, FSIR, an Btherapy increases survival, accord- 44 received PHP and 49 had interventional radiologist at Swedish ing to a Phase III trial reported at the standard treatment (typically systemic Medical Center in Denver. Symposium on Clinical Interventional • chemotherapy). In the latter group, 27 “There are very limited therapeutic Oncology (CIO), in collaboration patients began receiving PHP when options for these patients. This minimally february 25, 2011 with the International Symposium on their disease progressed. Patients in invasive therapy technology could even- Endovascular Therapy (ISET). Minimally the PHP group averaged 186 days be- tually be used to treat other liver cancers invasive chemosaturation delivers high fore the disease progressed compared when options are limited.” doses of chemotherapy into the liver with 46 days for patients who did not PHP involves delivering chemother- to more effectively battle tumors while receive PHP. apy via an arterial catheter threaded limiting toxicity to the rest of the body, Those in the PHP group benefi tted through the blood vessels to the liver. the researchers said. from an average of 245 days without Two balloons are infl ated in the vena In the multicenter randomized progression of cancer in the liver vs cava, above and below the liver to iso- trial, patients with melanoma that had only 49 days for those in the standard late the chemotherapy. This chemo- spread to the liver who underwent treatment group, a fi ve-fold increase. therapy-saturated blood is then percutaneous hepatic perfusion (PHP) “The minimally invasive method cleansed by a series of fi lters and re- survived four times longer before isolates the drug so it is contained turned to the body. PHP allows the the disease progressed, compared within the liver, where tumors receive entire liver to be treated, which is ben- with patients who did not receive the up to 100 times the dose they would efi cial in patients with more than one O treatment. get through systemic chemotherapy,” tumor. T ➞ODAC for cetuximab; tositumomab and Iodine S. Lin, MD, PhD, Director of Clinical I 131 tositumomab; clofarabine; ne- Development for GlaxoSmithKline continued from page 8 larabine; panitumumab; and imatinib Oncology, cited as a primary obstacle the mesylate. collection of CT scans. He noted that review and would like to have an annual Paul Eisenberg, MD, MPH, Amgen, some institutions do not have enough stor- ODAC review of accelerated-approval Inc. Global Regulatory Affairs & Safety of- age space to store physical scans, and so drugs to see where they are in the process fi cial, noted that a confi rmatory trial on an they destroy them. Privacy issues in hav- of confi rmatory trials to show clinical accelerated-approval cancer drug can lead ing outside radiologists review scans are benefi t. to challenges that ultimately could prove another problem, he said. He noted that several companies have benefi cial for patients. He cited panitu- told the FDA that they really didn’t want mumab for chemorefractory metastatic ODAC also agreed that to come to such a review meeting and were colorectal cancer as an example. going to consider withdrawing their can- “The discovery of KRAS as a bio- confi rmatory trials didate drugs. One problem: conducting marker changed the clinical landscape a randomized confi rmatory clinical trial of metastatic colorectal cancer,” said Dr. should be under way at when the drug has already demonstrated Eisenberg. the time a cancer drug clinical benefi t is problematic. However, He noted that the lack of availability post-marketing studies need not be car- of a validated test kit for KRAS has been receives accelerated ried out in the same population for which an obstacle, but that Amgen is now work- the drug was approved, according to FDA ing with a test kit manufacturer to design approval, since more regulations. a test that will identify this biomarker. timely completion of Dr. Eisenberg said Amgen plans a trial to Cetuximab, Tositumomab and confi rm clinical benefi t in patients with accelerated-approval Iodine I 131 Tositumomab; wild-type KRAS, and said, “We would ex- Clofarabine; Nelarabine; pect that full approval would be restricted confi rmatory trials Panitumumab; & Imatinib to patients with wild-type KRAS.” could be enhanced if As a start on an annual review of acceler- In discussing post-marketing confi rma- ated-approval cancer drugs, ODAC mem- tory trials for tositumomab and Iodine I the confi rmatory trial bers heard reviews during the morning 131 tositumomab for patients with vari- session from offi cials representing spon- eties of non-Hodgkin’s lymphoma who is ongoing. sors of accelerated-approval indications have not received rituximab, Thomas In presenting information on confi rma- tory trials on imatinib mesylate tablets for FDA Data on Accelerated-Approval the adjuvant treatment of adult cancer pa- tients following complete gross resection Cancer Drugs of Kit (CD117)-positive gastrointestinal stromal tumors (GIST), Laurie Letvak, • In 2011, there are 49 new indications for 37 oncology products. MD, Vice President and Global Program • Of these, 27 of 49 (55%) have had clinical benefi t confi rmed in post- Head at Novartis Pharmaceuticals Corp., marketing trials. cited several challenges the company has • Five of 49 (10.2%) have failed to confi rm a benefi t, and sponsors have encountered. or are in the process of withdrawing their indication after failing to complete She noted that multiple contracts and their confi rmatory trials. amendments with several legal entities in- • The proportion of indications failing to confi rm a benefi t has increased volved in cooperative groups “can be a bit slightly since 2005, when it was 7.1%. frustrating,” and echoing Dr. Pazdur’s • Under accelerated approval, cancer drug indications have been made comments, said the lesson is to collaborate available to patients a median of 3.6 years before post-marketing verifi cation early on in the process of doing post-mar- of their clinical benefi t. keting trials for accelerated-approval O cancer drugs. T.
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