bladder cancer

IMV Inc (NASDAQ: IMV) announced safety and preliminary efficacy data of the combination of its lead immunotherapy candidate, maveropepimut-S (MVP-S), with Merck & Co Inc's (NYSE: MRK) Keytruda (pembrolizumab) from a Phase 2 basket study in advanced, metastatic...

ImmunityBio Inc (NASDAQ: IBRX) achieved a significant milestone with over 80 subjects in the QUILT-3.032 study completing at least 12 months of follow-up as of January 14.  QUILT-3.032 is evaluating VesAnktiva plus BCG in subjects with BCG-unresponsive non-muscle invasive...

ImmunityBio Inc (NASDAQ: IBRX) announced data from its bladder cancer trial (QUILT-3.032) Phase 2/3 study of intravesical BCG plus Anktiva (N-803). The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle-invasive carcinoma in situ (NMIBC CIS)...

Seagen Inc (NASDAQ: SGEN) and Astellas Pharma Inc (OTC: ALPMF) announced the initial results from Cohort H of the EV-103 trial investigating PADCEV (enfortumab vedotin-ejfv) in muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy....

IMV Inc (NASDAQ: IMV) announced the finalization of the basket clinical study evaluating maveropepimut-S (MVP-S) in combination with Merck & Co Inc's (NYSE: MRK) Keytruda in patients with metastatic bladder and Micro-Satellite Instability High (MSI-H) solid tumors...

Sesen Bio Inc (NASDAQ: SESN) has outlined its anticipated regulatory path forward for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the FDA. Following the meeting, the Company has agreed to conduct a randomized...

The FDA has granted Sesen Bio Inc's (NASDAQ: SESN) request for a Type A meeting to discuss the Chemistry, Manufacturing, and Controls (CMC) issues raised in the Complete Response Letter for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer. Related: Sesen Bio...

ImmunityBio Inc (NASDAQ: IBRX) has announced that Papillary disease (Cohort B) of its Phase 2/3 study of intravesical BCG plus Anktiva met its primary endpoints with disease-free survival of 57% at 12 months.  Non-muscle invasive bladder cancer (NMIBC) makes up 75%-85% of all...

Japan's Ministry of Health, Labor, and Welfare (MHLW) has approved Astellas Pharma Inc's (OTC: ALPMF) Padcev (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. Enfortumab vedotin is the first and...

Nektar Therapeutics Inc (NASDAQ: NKTR) has entered into a new oncology clinical collaboration with Merck KGaA (OTC: MKGAF) and Pfizer Inc (NYSE: PFE) to evaluate the maintenance regimen of NKTR-255 in combination with avelumab in bladder cancer study. The Phase 2...

Janssen, a unit of Johnson & Johnson (NYSE: JNJ), announced results from the Phase 1b/2 NORSE study evaluating Balversa (erdafitinib) plus cetrelimab combination. The trial included patients with locally advanced or metastatic urothelial carcinoma (mUC) with fibroblast...

The FDA gave its full approval to Merck & Co Inc's (NYSE: MRK) Keytruda as a treatment for first-line advanced urothelial carcinoma (bladder cancer) patients who are not eligible for platinum-based chemo. Keytruda earned an accelerated nod in first-line locally advanced...

Two weeks ago, Sesen Bio Inc (NASDAQ: SESN) was on the cusp of winning FDA approval for the cancer drug Vicineum. It was working toward authorization in Europe. Now, with the FDA rejecting Vicineum for bladder cancer, Sesen has pulled its filing to the European Medicines Agency...

Bristol Myers Squibb & Co (NYSE: BMY) has snatched another U.S. license for Opdivo (nivolumab), this time in bladder cancer. The FDA has granted approval for Opdivo for the treatment of bladder cancer at high risk of recurrence after radical surgical resection, regardless of...

Sesen Bio Inc (NASDAQ: SESN) said that it was not expecting a CRL from the FDA for its bladder cancer candidate Vicineum.  But the rejected filing includes several violations and investigator misconduct, STAT News reported. Related: Sesen Bio Stock Crashes As FDA Shoots Down...