Search Results for “Astellas” – Page 2 – media

FDA signs off on new uses for Astellas and Pfizer’s Xtandi, Merck’s Keytruda

The FDA has signed off on label expansions for two of the world’s most important cancer medicines—Merck’s Keytruda and Pfizer and Astellas’ Xtandi. Keytruda’s expansion is in stomach cancer, allowing its use alongside chemotherapy to treat first-line patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. Xtandi’s new indication expands its already deep portfolio in the treatment of prostate cancer. It now becomes the only androgen receptor inhibitor approved by the FDA for patients with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). These patients can be treated with Xtandi with or without GnRH analog therapy. Of men who have had prostate cancer treatment, 20% to 40% will have BCR within 10 years. Of those with high-risk BCR, 90% will develop metastatic disease, with one in three dying. The nod was backed up by the phase 3 EMBARK ...
- Source: drugdu
- 117
- November 21, 2023
Apellis parries Astellas’ long-term Izervay data with 3-year results on its rival GA med Syfovre

After this summer’s FDA approval of Iveric Bio’s Izervay—the drug at the center of the $5.9 billion buyout by Japanese pharma Astellas—the battle for the geographic atrophy (GA) crown is on in the U.S. Now, Apellis Pharmaceuticals, which boasts embedded eye disease sales leader Syfovre, is putting up long-term data in a bid to outdo its new rival. Touting data from its GALE extension study, Apellis on Saturday said Syfovre yielded increasing treatment effects year over year and helped patients achieve more than a 40% reduction in non-subfoveal lesion growth at the study’s three-year mark. Apellis rolled out the latest GALE results as part of a presentation at this year’s meeting of the American Academy of Ophthalmology (AAO) in San Francisco. The timing coincides with the release of two-year data on Astellas and Iveric’s GA drug Izervay—also at AAO—which suggest the rival drug’s treatment benefit emerged in as few as ...
- Source: drugdu
- 112
- November 8, 2023
Seagen and Astellas’ Padcev, in Keytruda combo, delivers ‘practice-changing’ bladder cancer win

As Seagen prepares for its takeover by Pfizer, the company’s Astellas-partnered cancer drug Padcev has chalked up a key trial win—in combination with Merck’s Keytruda—in previously untreated metastatic bladder cancer. In the study, Seagen and Astellas’ antibody-drug conjugate Padcev and Merck’s PD-1 superstar Keytruda scored on both overall survival and progression-free survival compared with chemotherapy. An independent data monitoring committee found that the combo’s life extension benefit surpassed the pre-specified efficacy boundary at an interim analysis, the companies said in a Friday release. The results could open the combo up to patients who are eligible for platinum-based chemotherapies cisplatin or carboplatin, regardless of their PD-L1 status. “This study has the potential to be practice changing and offer a new standard of care for first-line metastatic bladder cancer,” Seagen’s R&D head Roger Dansey, M.D., said in the release. “We look forward to presenting the results at an upcoming medical conference and ...
- Source: drugdu
- 108
- October 4, 2023
Astellas withdraws IRA lawsuit after avoiding CMS’ price negotiations list

Expecting to be subject to Medicare pricing negotiations, Astellas in July challenged the legality of the Inflation Reduction Act (IRA). But now that the Centers for Medicare & Medicaid Services (CMS) has released the first 10 drugs set for governmental bargaining, the company is ready to abandon its litigation. When CMS last week revealed its list of the first 10 drugs eligible for Medicare price negotiations, Astellas’ Xtandi did not make the cut. This surprised some pharma watchers, who had expected the Pfizer-partnered cancer blockbuster to be among the first drugs to face the controversial new process. Now, without Xtandi on the list, Astellas is pulling its lawsuit, Reuters reports. The 10 drugs on the CMS’ list are blockbusters marketed by Johnson & Johnson, Bristol Myers Squibb, Merck & Co., Novartis, Eli Lilly, AstraZeneca, Novo Nordisk and Amgen. Many of the companies whose drugs made the cut had already filed ...
- Source: drugdu
- 189
- September 8, 2023
Astellas invests $50m to support advancement of Poseida’s cancer cell therapy

Astellas Pharma and Poseida Therapeutics have announced a strategic investment to support Poseida’s commitment to redefining cancer cell therapy. Under the terms of the agreement, Astellas will invest a total of $50m, including $25m to acquire 8,333,333 in shares of the common stock of Poseida, as well as a one-time $25m payment for a right of exclusive negotiation and the first refusal to licence one of Poseida’s clinical stage programmes. In oncology, Poseida’s research and development of cell and gene therapies for cancer and rare genetic diseases provides a broad pipeline of allogeneic CAR-T cell therapy product candidates for solid and liquid tumours. This includes P-MUC1C-ALL01, an allogeneic CAR-T cell therapy that is currently in phase 1 development for multiple solid tumour indications. The company has provided Astellas with a board observer seat to allow it to attend scientific advisory board meetings, as well as certain notice rights related to ...
- Source: drugdu
- 113
- August 11, 2023
Iveric Gets FDA Approval in Geographic Atrophy After Being Acquired by Astellas

By Tristan Manalac Pictured: Astellas’ American headquarters in Illinois/iStock, JHVEPhoto The FDA on Friday approved Iveric Bio’s intravitreal avacincaptad pegol, now to be marketed as Izervay, for the treatment of geographic atrophy secondary to age-related macular degeneration. The regulatory win comes three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion. The companies completed the acquisition last month. Friday’s approval makes Izervay the first authorized geographic atrophy (GA) treatment that has significantly slowed down GA progression at 12 months across two Phase III studies, according to Astellas’ announcement. The eye injection also offers a new treatment option to physicians and patients across the U.S., Iveric Bio President Pravin Dugel said in a statement. Discovered and developed by Iveric, Izervay is an intravitreally administered inhibitor of the complement C5 protein. By blocking the cleavage of C5, the eye injection also disrupts more downstream processes, including the formation ...
- Source: drugdu
- 209
- August 9, 2023
Astellas Strikes Another Deal to Expand in Cancer, Partnering With PeptiDream

Photo: Kiyoshi Ota/Bloomberg, via Getty Images Astellas Pharma is far from alone in viewing cancer as a major growth area, but the Japanese drugmaker has specifically identified a type of therapy called targeted protein degradation as one of the key areas for increasing revenue. It just struck its second deal in the past two months to help it execute on that strategy and perhaps stand apart from others pursuing the same type of drugs. Under a partnership announced Tuesday, Astellas will work with PeptiDream to discover new protein degraders using the technology of that company. Specific targets were not disclosed, but they will be selected by Astellas. The deal also grants Tokyo-based Astellas the option to select up to three additional targets for inclusion in the collaboration. Astellas will pay PeptiDream 3 billion yen (about $21 million) up front. PeptiDream, based in Kawasaki, Japan, is eligible to receive up to ...
- Source: drugdu
- 115
- July 27, 2023
J&J, Astellas Join Pharma Lawsuits Over Medicare Drug Price Negotiations

Pictured: Gavel on desk/Courtesy, iStock Astellas and Johnson & Johnson have filed lawsuits against the Medicare program, challenging the constitutionality of the Inflation Reduction Act’s drug pricing provisions. These legal actions add to a growing wave of litigation from drugmakers seeking to block the implementation of the Medicare Drug Price Negotiation Program. The IRA, designed to address rising healthcare costs and make medications more affordable for Americans, has faced significant opposition from the pharmaceutical industry. Friday, Astellas filed a lawsuit challenging the program, arguing that it violates the Fifth Amendment by unlawfully depriving them of their intellectual property rights. The pharma claimed that the IRA’s provisions, which allow Medicare to negotiate drug prices directly with manufacturers, amount to an unconstitutional confiscation of their patented drugs. Tuesday, J&J also filed a lawsuit against the Biden administration over the Medicare Drug Price Negotiation Program. The company asserted in its filing that the program is ...
- Source: drugdu
- 104
- July 21, 2023
Astellas Gains FDA Priority Review for Gastric Cancer Therapy BLA

The US Food and Drug Administration (FDA) has awarded priority review for Astellas Pharma’s biologics licence application (BLA) for zolbetuximab to treat gastric cancer patients. Zolbetuximab is an investigational monoclonal antibody that acts on Claudin 18.2 (CLDN18.2). It is intended for use as a first-line therapy for HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma that is locally advanced, unresectable or metastatic, with tumours that are CLDN18.2-positive. Zolbetuximab is the first treatment targeting CLDN18.2 to be offered in the region for such patients. A decision on the approval by the regulatory agency is anticipated on 12 January 2024. The application is based on the Phase III SPOTLIGHT and GLOW clinical trial findings. Zolbetuximab was assessed along with a regimen comprising oxaliplatin, leucovorin and fluorouracil (mFOLFOX6) in the SPOTLIGHT trial. The GLOW trial analysed zolbetuximab in combination with a chemotherapy regimen comprising capecitabine and oxaliplatin (CAPOX). Astellas immuno-oncology development ...
- Source: drugdu
- 121
- July 11, 2023
With Iveric Bio buyout, Astellas CEO Naoki Okamura acted on the company’s mantra to be ‘aggressive’

Earlier this year, when Astellas announced that Naoki Okamura was taking over as CEO, the Japanese company said that 2023 was the right time for it to “go on the aggressive to further stimulate growth.”It took Okamura less than a month into his tenure—which began April 1—to act on the company’s game plan. On April 29, he struck the largest acquisition in Astellas’ history, a $5.9 billion buyout of Iveric Bio. With the New Jersey-based biotech two months away from an FDA decision on its geographic atrophy (GA) eye disease candidate Zimura, Astellas hopes to become a major player in a new arena. “We had been closely watching the lead program for Iveric for a very long time, probably seven, eight years,” Okamura said in an interview with Fierce Pharma. “Because the modality of that project is very new to us, we were kind of hesitant to do any partnerships ...
- Source: drugdu
- 113
- June 15, 2023

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