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BioWorld - Monday, April 20, 2026
Home » Topics » Cancer, BioWorld

Cancer, BioWorld
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TG wins first approval with accelerated nod for Ukoniq

Feb. 5, 2021
By Jennifer Boggs
Executives of TG Therapeutics Inc. have promised a big year in 2021 and the company got off to strong start with accelerated FDA approval of umbralisib in marginal zone lymphoma and follicular lymphoma. Branded Ukoniq, the drug is the first oral, once-daily inhibitor of PI3K delta and CK1 epsilon and TG’s first commercial product. Pricing for Ukoniq has not yet been disclosed.
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FDA Approved stamp with pills

EMD Serono wins accelerated FDA approval for targeted NSCLC drug

Feb. 4, 2021
By Michael Fitzhugh
Just weeks after seeing one late-stage candidate hit a wall in a subtype of non-small-cell lung cancer (NSCLC), Merck KGaA's EMD Serono has won accelerated approval from the FDA for another important NSCLC therapy, Tepmetko (tepotinib).
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Kidneys

Street hails Cabo, driver of Exelixis; pair fares well in RCC

Feb. 4, 2021
By Randy Osborne
Probably no one was surprised by the FDA’s recent nod for the combination of Alameda, Calif.-based Exelixis Inc.’s tyrosine kinase inhibitor, Cabometyx (cabozantinib), which targets MET, AXL and VEGF, and PD-1 drug Opdivo (nivolumab) from Bristol Myers Squibb Co. as a first-line treatment for advanced renal cell carcinoma (RCC), but investors may feel less confident about the odds for the pairing in a competitive space.
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Robotic cancer removal intervention

Europe sets sites on turning cancer tide in midst of the pandemic

Feb. 4, 2021
By Mari Serebrov
In a task made more challenging by COVID-19, the EU and the World Health Organization are rolling out separate plans to take down cancer in Europe. The European Commission Feb. 3 announced its Europe’s Beating Cancer Plan, the first comprehensive European cancer initiative in nearly 30 years. A day later, WHO/Europe launched its United Action Against Cancer, billing it as a “pan-European cancer movement” to galvanize support and cooperation from grassroots to governments with the long-term goal of eliminating cancer as a life-threatening disease in the region.
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KRAS protein
WCLC 2021

KRAS drugs may do best in tough subtype

Feb. 4, 2021
By Anette Breindl
KRAS is the most frequently mutated oncogene in solid tumors in general, and in lung tumors in particular. There are more patients whose lung tumors are driven by KRAS mutations than by ALK, Ros, Ret and TRK alterations. Combined. And after 40 years, they look to be getting a targeted therapy, or even two.
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Sore throat illustration

For head and neck cancer, it's all about making Keytruda better

Feb. 2, 2021
By Brian Orelli
With the FDA approval of Keytruda (pembrolizumab, Merck & Co. Inc.) in the front-line setting of metastatic or unresectable, recurrent head and neck cancer squamous cell carcinoma, the space has become a race to develop drugs using a variety of mechanisms of action to improve the efficacy of the anti-PD-1 monoclonal antibody.
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Return arrow

Hairy situation? Innate’s Lumoxiti give-back rattling to some

Jan. 28, 2021
By Randy Osborne
Innate Pharma SA’s unexpected return to partner Astrazeneca plc all rights, in the U.S. and EU, to Lumoxiti (moxetumomab pasudotox-tdfk) for hairy cell leukemia likely triggered unease in at least some investors.
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Leukemia illustration

Medigene discontinues TCR-T program in blood cancers

Jan. 28, 2021
By Lee Landenberger
In light of its ongoing restructuring of priorities, Medigene AG, of Planegg/Martinsried, Germany, is now discontinuing its MDG-1021 development program. The company was planning a phase I study of the T-cell receptor-modified T-cell (TCR-T) therapy that targets the antigen HA-1 in patients with relapsed or persistent blood cancers after allogeneic hematopoietic stem cell transplantation.
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Human NK cell

Artiva crafts rich new CAR-NK deal with Merck targeting solid tumors

Jan. 28, 2021
By Michael Fitzhugh
Little more than half-a-year after closing its $78 million series A financing, Artiva Biotherapeutics Inc. has inked a new global licensing deal with Merck & Co. Inc. to develop up to three natural killer (NK) cell therapies engineered with chimeric antigen receptors (CAR) against tumor-associated antigens of its choosing. Merck will pay Artiva $30 million up front for two initial programs, plus $15 million more should it opt into the third. Each program carries $612 million in potential development and commercial milestone payments. With unfettered success, total deal value could hit $1.88 billion, plus royalties.
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Cancer cells
Newco news

Market ‘solutes’ Nirogy small-molecule flag with $16.5M series A

Jan. 26, 2021
By Randy Osborne
Boston-based Nirogy Therapeutics Inc.’s $16.5 million series A round is meant to enable a pipeline of small-molecule drugs targeting the solute carrier family of transporter proteins (SLCTs) embedded in the cell membrane, and let the firm bring its front oncology runner to the clinic in 2022.
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