Leukemia Drug Lumoxiti to be withdrawn From US Market
- Lumoxiti (moxetumomab pasudotox-tdfk) for injection is expected to be permanently discontinued by August 31, 2023, according to a recent communication from the FDA.
- Lumoxiti, a CD22-directed cytotoxin, was approved by the FDA in September 2018 for the treatment of adults with R/R hairy cell leukemia who received at least 2 prior systemic therapies.
- The decision to remove Lumoxiti from the US market was related to its very low clinical uptake due to the availability of other treatment options and not related to the safety or efficacy of the drug.
- Physicians are advised not to initiate new treatment with Lumoxiti.
- The postmarketing study evaluating the safety of Lumoxiti (ClinicalTrial.gov Identifier: NCT04125290) will also be terminated.
Share:
More News
Lamine Mbow, Global Head of Discovery Research, Boehringer Ingelheim, said: “We are building a broad pipeline of ADCs addressing novel tumor target space to develop next-generation cancer treatments. By combining our deep expertise in cancer treatment development with Synaffix’s clinical-stage platform technology, we aim to accelerate the delivery of first-in-class
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, M.D., Chief Oncology Officer, Pfizer. “These
“Receiving FDA IND clearance is an important milestone in the advancement of TYRA-300 and for patients with NMIBC who urgently need better tolerated therapeutic options,” commented Doug Warner, Chief Medical Officer of TYRA. “We look forward to leveraging Erik’s impressive background to guide our development plans in NMIBC. We expect
“As a leader in hematologic malignancies, AbbVie is committed to advancing innovative treatments for complex cancers like multiple myeloma through our relentless R&D efforts and collaborations,” said Mariana Cota Stirner, M.D., Ph.D., vice president, therapeutic area head for hematology, AbbVie. “We look forward to partnering with Simcere Zaiming, to advance
