by
Lauren Dubinsky, Senior Reporter | June 17, 2016
From the June 2016 issue of HealthCare Business News magazine
Keep your eye on these
Gallium-68 compounds, derived from Germanium-68/Gallium-68 generators, for imaging somatostatin receptors have recently become more prominent, says Lapi. This has the potential to label many ligands and would also offer improved PET imaging capabilities for tumors and other diseases in the future.
Choline C-11 holds promise for cardiac and oncologic use, but more specifically prostate cancer. In November 2015, Zevacor Molecular announced FDA approval of ANDA for Choline C-11, making the company the only approved commercial manufacturer of the radiopharmaceutical. Prostate cancer patients typically are diagnosed through a rectal exam or with a blood test called PSA, which evaluates a specific protein that, when elevated, signifies cancer. When the patient receives the initial treatment, his PSA level usually falls to zero.
Many of the patients often experience some sort of biochemical recurrence after the initial treatment and undergo a bone, CT or MR exam so the physician can determine the location of the cancer. If the physician can’t determine the cancer’s location, the patient will be treated with chemotherapy or radiation of the pelvis. However, the patient may still have cancer in a specific part of the body and it will often go from early-stage to stage 3 or 4 before the physician detects it.
Early detection and treatment
“The whole significance of Choline C-11 is that now we have the tool [with which] we can help identify early recurrence,” says Peter Webner, vice president of clinical development at Zevacor Molecular. “The key to long-term survival is early detection and treatment and, if at all possible, targeted treatment.”
The major challenge with Choline C-11 is that it has a 20-minute half-life, meaning Zevacor has to quickly get it to its customers so they can use it within an hour and a half time frame. Because of that, it has very limited distribution, but Webner believes it’s worth it because it’s a very sensitive product that will help the patients get treated sooner.
Prostate-specific membrane antigen (PSMA) is the ultimate goal for prostate cancer imaging. Webner believes there will be radiopharmaceuticals in the future that will be able to directly localize PSMA, which will help reduce false positives and increase specificity. However, that may not be for several years, so all physicians have for now is Choline C-11. “Every urology group I have spoken with in the past few years said it’s an unmet need for them,” says Webner. “They realize it has its limitations and it’s not a perfect product, but right now there is nothing else for them to use.”
