AstraZeneca is on the right track to get a first-line indication in Europe for Tagrisso in lung most cancers, after a CHMP beneficial approval at its assembly final week.The go-ahead comes only a few days after Tagrisso (osimertinib) was permitted by the FDA for a similar indication – previously-untreated sufferers with EGFR-mutated non-small cell lung most cancers – which is regarded as key to unlocking its gross sales potential. Tagrisso can also be knocking on the door of $1bn in annual gross sales from its use in second-line NSCLC, however AZ thinks front-line use will assist drive gross sales above the $3bn-a-year mark.The CHMP’s constructive opinion is predicated on the outcomes of the FLAURA trial, which confirmed Tagrisso was in a position to nearly halve the danger of a secondary development or dying versus comparator EGFR inhibitors together with Roche’s Tarceva (erlotinib) or AZ’s earlier-generation EGFR drug Iressa (gefitinib).There was additionally excellent news on the CHMP assembly for Gilead Sciences’ HIV division, with the panel giving its blessing to three-drug, fixed-dose remedy Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). Gilead is locked in a fierce battle with GlaxoSmithKline’s three way partnership unit ViiV for dominance in HIV-1 remedy, and Biktarvy is vital to its progress plans as a riposte to Triumeq (abacavir/dolutegravir/lamivudine), at the moment spearheading a acquire in HIV market share for Viiv.Gilead reported new knowledge final month exhibiting that it was attainable to change from Triumeq to Biktarvy with no lack of efficacy and – it claims – fewer unwanted side effects.Roche picked up an vital new approval advice for its HER2-targeting drug Perjeta (pertuzumab) as an adjuvant (post-surgery) therapy for HER2-positive breast most cancers at excessive danger of recurrence alongside its older HER2 drug Herceptin (trastuzumab).The corporate is positioning Perjeta as a successor to HER2 stalwart Herceptin – which is beginning to really feel the consequences of biosimilar competitors – and approval for adjuvant use is one other step in the direction of reaching the identical breadth of makes use of as its predecessor. The FDA permitted adjuvant use of Perjeta final December, and pre-surgery (neoadjuvant) use to shrink tumours within the EU, US and different nations.Among the many different highlights from the CHMP assembly was the withdrawal by AstraZeneca (AZ) of an software to market diabetes mixture Qtern (saxagliptin/dapagliflozin). This was permitted within the US final 12 months, however has seen its gross sales projections pegged again by a number of delays on its strategy to market.There was a advice for an under-the-tongue formulation of potent analgesic sufentanil from FGK consultant Companies – underneath the Dzuveo model identify – and a generic model of Bristol-Myers Squibb’s Carmubris (carmustine) for mind tumours, non-Hodgkin’s lymphoma and Hodgkin’s illness filed by Apparent Funding.There have been additionally new indications permitted for UCB’s Cimzia (certolizumab pegol), Amgen’s Prolia (denosumab), BMS’ Sprycel (dasatinib) and Yervoy (ipilimumab), Pfizer’s Xeljanz (tofacitinib), and Novo Nordisk’s Xultophy (insulin degludec/liraglutide).Lastly, three detrimental opinions on advertising functions have been appealed, based on the CHMP. The three medication in query are Portola’s anticagulant Dexxience (betrixaban), Radius’ osteoporosis candidate Eladynos (abaloparatide) and AB Science’s Alsitek (masitinib), filed for neurodegenerative illness amyotrophic lateral sclerosis (ALS).


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