BioCentury
ARTICLE | Product Development

Sept. 20 Quick Takes: Seagen, Genmab prepping launch of ADC for cervical cancer

EC pressures Illumina, Grail; March PDUFA date for Bristol’s LAG3 combo; biosimilar Lucentis approval and more

September 21, 2021 2:21 AM UTC

With FDA’s accelerated approval Monday of Tivdak tisotumab vedotin-tftv to treat cervical cancer, the product will be the first for which Genmab A/S (CSE:GMAB; NASDAQ:GMAB) will take on commercial responsibilities, the result of a strategic shift three years ago to retain more commercial rights. It’s also the first approved antibody-drug conjugate for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tivdak, which had an Oct. 10 PDUFA date and is partnered with Seagen Inc. (NASDAQ:SGEN), has a black box warning describing risks of ocular toxicity. The therapy comprises a Genmab human mAb directed to tissue factor and Seagen’s ADC technology, which uses a protease-cleavable linker that covalently attaches microtubule-disrupting agent monomethyl auristatin E to the antibody.

Illumina Inc. (NASDAQ:ILMN) and  Grail Inc. face measures by the European Commission seeking to maintain competition and are at risk of being penalized 10% of their annual turnover after the genomics company completed its $8 billion acquisition of Grail before the EC had finished its review of the deal. It’s the first time the EC plans to adopt interim measures following what it says is an “unprecedented” early implementation of a transaction it is investigating. After hearing the companies’ response to the EC’s objections to the deal, the commission may make the interim measures binding...