Petrylak Provides Perspective on the Nationwide Cisplatin/Carboplatin Shortage

The ongoing shortage of carboplatin and cisplatin across healthcare systems in the United States calls the current reliance on overseas manufacturing of these vital therapies into question, according to Daniel P. Petrylak, MD, who added that shifting the production of platinum-based chemotherapies back to the United States may serve to prevent future shortages.

“The bottom line is that these drugs should be produced here,” Petrylak emphasized in an interview with OncLive®. “We need to understand why this has not been feasible for generic pharmaceutical companies or for larger pharmaceutical companies to produce these drugs in this country.”

In an interview, Petrylak, a professor of medicine and urology and coleader of Cancer Signaling Networks at Yale Cancer Center, discussed strategies he and his colleagues at Yale Cancer Center have employed to reduce the effect of the current chemotherapy shortage on patients, and emphasized the need to reassess current manufacturing strategies in an effort to potentially mitigate future drug shortages.

OncLive: How has the ongoing cisplatin/carboplatin shortage affected clinical practice both nationwide and at your own institution?

Petrylak:At the beginning, we were told to be selective about who we’re giving cisplatin to, and that the [patients with] germ cell tumors [are] our priority in terms of high curability. Carboplatin can’t be substituted, and at that time, [the shortage] was just [of] cisplatin. We had 1 patient who was on neoadjuvant therapy for urothelial carcinoma, who we switched to carboplatin for 1 cycle, and then we were able to switch back to cisplatin. [The impact of the shortage] hasn’t been as severe, here, [at Yale]. [However,] I’m hearing from colleagues that it’s [more] severe depending upon the region. We’ve been fortunate, [but] other areas have been less fortunate.

What measures should be undertaken to ensure that patients, particularly ones in the curative-intent setting, can access necessary treatment during the shortage?

The pharmacies have been hard at work making sure that we have an adequate supply [of platinum agents], but [the necessity of] this begs the question: Why has this happened [in the first place]? From what I understand, the FDA has shut down a couple of [manufacturing] sites in India that were producing cisplatin and carboplatin due to quality control issues.

We must make it more feasible for these drugs to be produced here. This way, we’re not reliant upon a source outside of this country for our drugs. We have to investigate the reasons why these drugs can’t be produced here—either it’s not financially feasible, or there’s some other reason. We need to explore that carefully and then see how we can [change] this, not only for [the manufacturing of] cancer drugs, but [also] for antibiotics.

How have you and your colleagues approached conversations about the current shortage with patients whose treatment may be affected?

We’ve explained [the shortage] by saying that there are alternatives for treatment. It’s a non-issue for the patients with germ cell tumors [because they] have to get cisplatin. For a patient who is ineligible to receive cisplatin and eligible to receive carboplatin, one could go forth with the alternative FDA-approved combination of enfortumab vedotin [Padcev] and pembrolizumab [Keytruda]. It has a different adverse effect pattern, but nonetheless, has significant efficacy in this patient population.

There are [treatment] alternatives, and they need to be discussed. We need to emphasize to patients that we are taking the best possible care of them at this time, given the circumstances.

What else can be done to ensure medical institutions are prepared for potential drug shortages? What could be done to prevent their occurrence in the future?

These drugs have a shelf life, so there’s only so much you can do in terms of stockpiling these drugs. [Ultimately, platinum chemotherapy drugs] should be produced in the United States and we should have our own supply. These drugs are off patent. That may not be as profitable, but they’re still necessary.