If you can’t beat them, join them. After Bristol Myers Squibb’s Opdivo topped Seagen’s classical Hodgkin lymphoma (cHL) therapy Adcetris in a head-to-head trial, Seagen has trotted out new datasets suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together as part of a combination. In a midstage study, all patients with early-stage cHL who received a combination of Adcetris, Opdivo and the chemotherapy regimen AD (doxorubicin and dacarbazine) were alive without disease progression after one year of treatment. The analysis came from 150 patients enrolled in part C of the phase 2 SGN35-027 trial and was shared at the 65th American Society of Hematology annual meeting. The data look promising, but cHL is known to be relatively easy to treat. In an interview, Megan O’Meara, M.D., Seagen’s head of clinical development, acknowledged that people want to see longer-term data—and ultimately a survival benefit—in frontline cHL. ...
Roche announces positive phase 3 results for Alecensa in early-stage lung cancer Roche has shared new results from a late-stage study of its anaplastic lymphoma kinase (ALK) inhibitor Alecensa (alectinib) in early-stage lung cancer. The phase 3 ALINA study has been evaluating the targeted drug as an adjuvant therapy in patients with completely resected stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC). Alecensa was shown to reduce the risk of disease recurrence by 76% compared with platinum-based chemotherapy, Roche said. A clinically meaningful improvement of central nervous system disease-free survival was also observed in those receiving Alecensa, and the safety and tolerability of the therapy were consistent with previous trials in the metastatic setting. Overall survival data was immature at the time of this analysis and the company has outlined that follow-up is ongoing to “report a more mature estimate”. Levi Garraway, Roche’s chief medical officer and head ...
The U.S. Food and Drug Administration today approved Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.
Seattle Genetics, Inc. (SGEN) announced that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Primary cutaneous ALCL and MF are the most common subtypes of cutaneous T-cell lymphoma (CTCL).
After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
Takeda’s Fruzaqla (fruquintinib) has been approved by the US Food and Drug Administration (FDA) for use in certain patients with previously-treated metastatic colorectal cancer (mCRC). Fruzaqla, which inhibits all three VEGF receptor kinases, has been specifically authorised for use in adults with mCRC who have been previously treated with chemotherapy, an anti-VEGF therapy, and in some cases, an anti-EGFR therapy. The FDA’s decision makes Fruzaqla the first targeted treatment options approved in the US for metastatic CRC regardless of biomarker status or prior therapies in more than a decade and was supported by results from the late-stage FRESCO and FRESCO-2 trials, which evaluated Fruzaqla plus best supportive care versus placebo plus best supportive care in previously-treated mCRC patients. Both trials met their primary and key secondary efficacy endpoints and showed consistent benefit among a total of 734 patients treated with Fruzaqla, Takeda said, adding that the drug demonstrated a “manageable ...
The US Federal Trade Commission (FTC) has requested more information and documentary material regarding Pfizer’s proposed $43bn acquisition of Seagen. The second request is a standard review procedure by which the FTC and the Antitrust Division of the US Department of Justice investigate mergers and acquisitions. If a second request is submitted, the law forbids merging companies from completing a transaction until they have substantially complied with the additional investigatory request. The Pfizer/Seagen agreement, which was originally announced in March this year, would mark a significant boost to the US pharma’s oncology pipeline. At the time of the announcement, Pfizer’s oncology portfolio included 24 approved drugs, while Seagen’s included Adcetris for lymphomas, Padcev for bladder cancers, Tivdak for cervical cancer, and Tukysa for breast and colorectal cancers. The deal would also grant Pfizer access to Seagen’s drug development pipeline as well as its proprietary ...
David Epstein’s short tenure as Seagen’s CEO will likely end soon with the antibody-drug conjugate specialist’s sale to Pfizer. After a rich career spanning companies of various sizes, Epstein is keeping an open mind about where he might head next.“I will hopefully make new drugs somewhere else,” Epstein said in a recent interview on the sidelines of the American Society of Clinical Oncology’s annual meeting. “I don’t know where that will be.” Throughout his time in biopharma, Epstein has worn many hats. He’s known for building Novartis’ oncology unit and leading the Swiss giant’s larger global pharma business. He fostered startups for five years at Flagship Pioneering before taking the reins at Seagen in November. Those roles have given him experience in almost every therapeutic area and in both drug development and commercialization. That kind of resume opens a lot of possibilities—although going back to Flagship isn’t his plan right ...
The US Food and Drug Administration (FDA) has approved brentuximab vedotin (Adcetris) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
The year’s merger-and-acquisition trend continues. Today, the last day of January, Bothell, Washington-based Seattle Genetics announced it is buying Seattle-based Cascadian Therapeutics for about $614 million.
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