The PD-1 inhibitor was also cleared for shorter, 30-minute infusions across its approved indications, according to the biopharmaceutical company.
“From the introduction of our first immuno-oncology agent through today’s approval of flexible dosing options at two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community,” Johanna Mercier, head of the company’s U.S. commercial biz, said in prepared remarks. “With this approval, we now offer the most robust range of dosing options for an immuno-oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.”
“We continuously learn new ways to individualize treatment with immuno-oncology therapies, and in my experience, what works for one patient may not be optimal for another,” Dr. Jeffrey Weber, deputy director of the Perlmutter Cancer Center at NYU Langone Health, added. “For instance, some patients may need the support of two-week visits with their healthcare team, while for others, a four-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”
Bristol-Myers Squibb’s Opdivo product works by blocking the mechanism that tumors use to hide from a patient’s immune system. After landing FDA approval in a number of indications, Bristol-Myers Squibb is also testing Opdivo in nine late-stage adjuvant trials and as a maintenance therapy for patients with small-cell lung cancer, according to Reuters.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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