Linkedin
RLS logo_header
Linkedin

U.S. FDA accepts BLA for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

“We believe subcutaneous nivolumab has the potential to make a significant difference in the lives of patients, which is reinforced by the FDA’s acceptance of our application,” said Gina Fusaro, Ph.D., vice president, global program lead, Bristol Myers Squibb. “Opdivo is a foundational PD-1 inhibitor approved for many different types of cancer, and our continued investment in research that puts patients first remains a priority. If approved by the FDA, the subcutaneous administration of nivolumab would provide patients and their physicians with a new option that delivers the same well-known benefits as IV Opdivo but with the improved convenience of an injection administered in three-to-five minutes rather than a 30-to-60-minute infusion.”

Read the full story on "U.S. FDA accepts BLA for Subcutaneous Nivolumab (nivolumab and hyaluronidase)"

Share:

More News

SC Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior PK Compared to IV KEYTRUDA in Pivotal 3475A-D77 Trial

“KEYTRUDA has helped transform the treatment of certain cancers, and we continue to pursue innovations that build on this breakthrough medicine to give patients and those who treat them better experiences,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “If approved,

FAILED TRIAL: Ph 3 ARTISTRY-7 Trial of Nemvaleukin + KEYTRUDA in Patients with Platinum-Resistant Ovarian Cancer did not achieve a statistically significant improvement in OS

“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to

Primary Endpoint Met in Pivotal Ph 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

“The improvement in survival seen in ROSELLA, without an increased safety burden, brings us closer to delivering a new standard-of-care treatment for patients with platinum-resistant ovarian cancer,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “We deeply appreciate the patients and investigators who participated in the trial, and we look

Ph 3 Study Design Finalized with FDA for IMNN-001 in Newly Diagnosed Advanced Ovarian Cancer

“We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial,” said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. “The Phase 2 OVATION 2 study data are

Onco-This-Week

About Us

Sign up for OTW

Linkedin

Disclaimer: The OTW team takes care to share authentic information. In case of any discrepancies please write to newsletter@onco-this-week.com. Our website is an aggregator for open-source oncology news. The information on our website is provided without any representations or warranties. OTW is part of RLS Consultants, a global consulting and training firm focusing exclusively on the healthcare and life sciences industries. RLS is a leading provider of opportunity assessment services, utilizing its comprehensive expertise in strategic market research, forecasting, and modeling, as well as pricing and market access to facilitate commercial assessments. RLS does not have any influence on any news reported on OTW. The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of RLS. The content on our website is intended strictly for news and information purposes only and should not be treated as a substitute for medical advice, diagnosis, or treatment. News shared on OTW should not be utilized in real-world analytic products as they are based only on limited and dated open-source information.