Category: bladder cancer

  • NICE reverses stance on Merck’s Bavencio for bladder cancer

    Last year, NICE said that Merck KGaA/Pfizer’s Bavencio was too expensive for routine in NHS use as a first-line maintenance treatment for bladder cancer, even though the drug is the only cancer immunotherapy approved for this use. Now, the cost-effectiveness agency has relented – with the help of an additional discount from the company – […]

  • Trial win sets up new use for Astellas, Seagen’s Padcev in bladder cancer

    Astellas and Seagen’s Padcev is on course to move further up the treatment pathway in bladder cancer, thanks to a positive readout in the EV-103 clinical trial. Padcev (enfortumab vedotin) is already approved as a second-line therapy for urothelial carcinoma (UC) after cisplatin chemotherapy and immunotherapy with checkpoint inhibitors, but Seagen and Astellas are working […]

  • NICE clears NHS use of Roche’s Tecentriq in bladder cancer

    NICE has recommended routine NHS access to Roche’s cancer immunotherapy Tecentriq for some bladder cancer patients, four years after it was first made available via the Cancer Drugs Fund (CDF). The PD-L1 inhibitor was initially turned down by NICE for a form of bladder cancer called urothelial carcinoma (UC), but Roche was encouraged to make […]

  • The Effects of Nutritional Yeast for Cancer 

    How can the beta glucan fiber in brewer’s, baker’s, and nutritional yeast improve wound healing and, potentially, anti-cancer immunity?  My video Benefits of Nutritional Yeast for Cancer opens with an image of an article titled “The Treatment of Inoperable Cancer.” It noted that “200 years ago it was observed that a certain number of malignant growths disappeared after an attack of erysipelas [a type of […]

  • BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

    Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who […]

  • Sesen Bio says rejected bladder cancer drug may need new clinical trial

    For much of this summer, Sesen Bio said all of the FDA’s communications pointed toward regulatory approval for the biotech’s bladder cancer drug. Though Sesen characterized the regulator’s rejection of the fusion protein as surprising, CEO Tom Cannell also revealed an earlier sign that another clinical trial may be necessary.

  • Scotland backs Bavencio for bladder cancer after NICE says no

    Patients with bladder cancer in Scotland will be the first in the UK to claim access to maintenance treatment with Merck Serono and Pfizer’s Bavencio, ahead of their counterparts in England and Wales. The Scottish Medicines Consortium (SMC) has cleared NHS funding for Bavencio (avelumab) as a first-line maintenance therapy for people with advanced urothelial […]

  • NICE says no to Merck Serono’s Bavencio in bladder cancer

    Merck Serono’s Bavencio is the only checkpoint inhibitor to be approved for first-line maintenance treatment of bladder cancer in Europe, but UK cost-effectiveness agency NICE says it is too expensive to justify routine NHS use.  Bavencio (avelumab) was approved in the UK earlier this year for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq

    Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes available next year.  That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional […]

  • Astellas, Seagen seek speedy reviews of Padcev in bladder cancer

    The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings.  One of the filings is to convert the ADC’s current conditional approval as a later-line therapy for urothelial cancer in patients […]

  • Roche’s Tecentriq loses bladder cancer use as FDA crackdown continues

    Roche’s Tecentriq is the latest medicine to fall foul of a crackdown by the FDA on drugs that have failed to live up to their early promise. The Swiss pharma said it is voluntarily withdrawing the US indication for the immunotherapy Tecentriq (atezolizumab) in metastatic urothelial carcinoma (mUC) previously treated with chemotherapy. As with AstraZeneca’s […]

  • Roche withdraws Tecentriq for bladder cancer, pullback comes amid FDA review

    Blockbuster Roche drug Tecentriq will be pulled from the U.S. market as a bladder cancer treatment—three years after failing clinical tests required to stay on the market. The voluntary withdrawal comes amid an industry-wide FDA review of drugs that were awarded accelerated approval but later failed confirmatory studies.

  • AstraZeneca to Withdraw Imfinzi Indication in Advanced Bladder Cancer in the US

    Shots: The company reported the voluntary withdrawal of the Imfinzi (durvalumab) indication in the US for prior treated adult patients with LA or metastatic bladder cancer. The withdrawal was made in consultation with the US FDA The withdrawal is aligned with FDA guidance for evaluating indications with accelerated approvals that did not meet post-marketing requirements […]

  • AZ withdraws Imfinzi in US bladder cancer use after trial failure

    AstraZeneca has suffered a setback after it voluntarily withdrew its cancer immunotherapy Imfinzi (durvalumab) in a bladder cancer indication in the US. AZ’s share price ticked downwards after the announcement that it will stop marketing Imfinzi, a PD-L1 class immunotherapy, for previously treated adult patients with advanced or metastatic bladder cancer. It’s news that will […]

  • Astellas/Seagen prepare full US filing of bladder cancer drug Padcev

    Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend. To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data […]

  • Merck, Pfizer get EU nod for Bavencio as bladder cancer maintenance

    Pfizer and partner Merck KGaA now have approval on both sides of the Atlantic for their checkpoint inhibitor Bavencio as a first-line maintenance therapy for bladder cancer, stealing a march on rival drugs in a highly competitive market. The European Commission has cleared Bavencio (avelumab) for locally advanced or metastatic urothelial carcinoma (UC) – the […]

  • Arsenic in Infant Rice Cereal

    When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible. “The US Food and Drug Administration (FDA) has been monitoring the arsenic content in foods” for decades, yet despite the “well-established science describing the health risks associated with arsenic exposure, no standards have […]

  • AZ aims to cut cancer clinic visits with new Imfinzi regimen

    The FDA is to review data supporting AstraZeneca’s Imfinzi (durvalumab) cancer immunotherapy in a new four-week regimen that will halve the number of required clinic visits for patients with lung and bladder cancer. The regulator has granted a faster six-month Priority Review for the fixed dose regimen, based on data from several Imfinzi clinical trials, […]