Asian drugmakers had a few busy days before the end of 2019. Daiichi Sankyo and partner AstraZeneca won FDA approval for HER2 antibody-drug conjugate Enhertu four months ahead of schedule. Astellas, while buying up CAR-T biotech Xyphos, secured an FDA go-ahead for its Seattle Genetics-partnered ADC Padcev in bladder cancer and notched a new prostate cancer indication for its Pfizer-shared Xtandi. And Chinese regulators waved through two homegrown rival vaccines to Pfizer's Prevnar 13 and Merck & Co.'s Gardasil, as well as BeiGene's PD-1 inhibitor tislelizumab and Zai Lab's Zejula, licensed from GlaxoSmithKline.
Daiichi Sankyo and AstraZeneca have gained an FDA approval for Enhertu, the key in their multibillion-dollar partnership. The nod followed a mere two-month priority review, and it came just days after the pair unveiled detailed registrational trial data. Phase 2 data showed the antibody-drug conjugate staved off cancer for a median of 16.4 months in previously heavily treated HER2-positive breast cancer patients.
In another antibody-drug conjugate approval the FDA doled out at the end of 2019, Seattle Genetics and Astellas’ Padcev was cleared for metastatic bladder cancer patients who have received chemo and a PD-1/L1 inhibitor. In a phase 2 study, the drug shrank tumors in 44% of patients and eliminated them in 12%.
Pfizer and Astellas’ Xtandi has won an FDA green light for metastatic, castration-sensitive prostate cancer three months after rival Johnson & Johnson’s Erleada landed a nod in the same indication. Regulators based their decision on data from a phase 3 trial, which showed a combination of Xtandi and standard androgen-deprivation therapy (ADT) cut the risk of disease worsening or death by 61% versus ADT alone.
Shortly after scooping up gene therapy biotech Audentes for $3 billion, Astellas is shelling out $120 million upfront to acquire Parker Institute-backed startup Xyphos. The small company uses an engineered NKG2D receptor that allows CAR-T therapies to be turned on only when they meet a bispecific. Such an approach could, in theory, reduce off-target effects and allow adjustment of CAR-T treatment strength.
Chinese drug regulators approved domestic drugmaker Walvax Biotechnology’s 13-valent pneumococcal conjugate vaccine, a rival to Pfizer’s Prevnar 13. Local firm Innovax’s bivalent HPV shot Cecolin has also won a go-ahead to enter the market currently held by Merck & Co.’s Gardasil family and GlaxoSmithKline’s Cervarix. But with demand surging, there may be room for everyone.
In a closely watched phase 3 study, BeiGene’s new BTK inhibitor Brukinsa failed to significantly outdo Johnson & Johnson and AbbVie’s Imbruvica at triggering complete responses in patients with Waldenstrom macroglobulinemia. Still, SVB Leerink analyst Andrew Berens viewed the results as favorable for the BeiGene drug, citing “largely an issue of statistical powering.” What’s more important, Brukinsa showed a better safety profile.
Eisai has won FDA approval for insomnia drug Dayvigo, of which the Japanese pharma took full ownership after it bought out Purdue Pharma’s stake in 2015. While the drug topped placebo in terms of patients’ sleep onset and time to uninterrupted sleep in two phase 3 trials, it also bears a warning label that includes daytime impairment, among other side effects.
Chinese scientist He Jiankui, who was widely condemned for using CRISPR to create the world’s first gene-edited babies, has been sentenced to three years in prison after being found guilty of “illegal medical practice.” He previously edited CCR5 in human embryos, a procedure he said could help the babies resist HIV infection.
Three years after Takeda chipped into Cerevance’s series A, the Japanese pharma is tapping the biotech to help identify protein targets in the central nervous system to develop treatments for gastrointestinal disorders. As Cerevance’s first partner, Takeda is putting down an upfront fee and research support funds and promised up to $170 million in milestones per target.
Sun Pharma’s Halol plant in India just can’t meet the FDA’s standards. After one observation in June, the key facility was slapped with a Form 483 with eight observations as a result of an inspection in December. No details of the issues were given, but the Indian company said it was committed to fixing the problems.
Other news of note
> GlaxoSmithKline partner Zai Lab has won a Chinese go-ahead for Zejula as maintenance therapy for platinum chemo-sensitive recurrent ovarian cancer regardless of BRCA mutation status. Its PARP inhibitor rival, AstraZeneca’s Lynparza, currently boasts approvals in first-line and recurrent maintenance settings in the country but only in BRCA-mutated cases. The approval marks the first for Zai Lab on the Chinese mainland. Release
> China has approved its seventh PD-1/L1 in BeiGene’s tislelizumab for patients with classical Hodgkin lymphoma who have received at least two prior therapies. In a single-arm phase 2 trial, the drug triggered an objective response rate in 76.9% of patients, with 61.5% in complete response. The drug will be manufactured by Boehringer Ingelheim at its Shanghai facility. Release
> Fujifilm is acquiring Hitachi’s diagnostic imaging business for JPY179 billion ($1.67 billion). Release (PDF)