Perform complete blood counts before and during treatment with PLUVICTO. One death due to sepsis and concurrent neutropenia was observed.
Two deaths (0.4%) due to intracranial hemorrhage and subdural hematoma in association with thrombocytopenia were observed. Grade ≥3 pancytopenia occurred in 1.1% of patients (including 2 fatal events). In the VISION study, grade 3 or 4 decreased hemoglobin (15%), decreased platelets (9%), decreased leukocytes (7%), and decreased neutrophils (4.5%) occurred in patients treated with PLUVICTO. PLUVICTO can cause severe and life-threatening myelosuppression. To minimize radiation exposure to others, advise patients to limit close contact (less than 3 feet) with household contacts for 2 days or with children and pregnant women for 7 days, to refrain from sexual activity for 7 days, and to sleep in a separate bedroom from household contacts for 3 days, from children for 7 days, or from pregnant women for 15 days. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with PLUVICTO consistent with institutional practices, patient treatment procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection.Įnsure patients increase oral fluid intake and advise them to void as often as possible to reduce bladder radiation. PLUVICTO contributes to a patient’s long-term cumulative radiation exposure, which is associated with an increased risk for cancer. The Swiss big pharma company has been steadily bulking up in cancer via bolt-on acquisitions, for example by buying up GlaxoSmithKline’s oncology assets in 2015 in a $16bn deal, acquiring US biopharma Admune Therapeutics and announcing a string of licensing deals for cancer candidates, mainly in immuno-oncology.PLUVICTO™ (lutetium Lu 177 vipivotide tetraxetan) is indicated for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy. Latterly Sandostatin has played second fiddle to Afinitor, which is rolling out in multiple NET tumour types including gastrointestinal and lung NET last year and brought in $1.1bn in the same period. The popularity of a long-acting version means it It’s still a big earner for Novartis however, with sales of around $1.2bn in the first nine months of this year, down just 4%. Novartis has no heritage in this type of medicine but already markets two drugs for NET – Sandostatin (octreotide) and Afinitor/Votubia (everolimus) – so the acquisition makes sense from a franchise perspective, particularly as Sandostatin has now lost patent protection for the immediate-release formulation.
AAA was spun out 15 years ago from Cern, the European nuclear research organisation.
#Netspot novartis plus#
With the acquisition, Novartis is aiming to add AAA’s Lutathera (Lutetium Lu177 dotatate) for treating gastroenteropancreatic neuroendocrine tumours (NET) – approved in the EU and heading for an FDA decision towards the end of January – plus two commercial NET imaging agents (NetSpot and Somakit) already generating revenues.Īdded to that, the acquisition adds a pipeline of early-stage radionuclide candidates for other types of cancer, including several solid tumours including prostate cancer.
The tender offer will expire at midnight on January 19 unless extended, said Novartis. Novartis offer to buy the company was made in October and – after negotiations with company’s works council – AAA’s board has now given its blessing to the $41 per share takeover, which values the French company at $3.9bn. Novartis has started its cash tender offer for French firm Advanced Accelerator Applications, which specialises in radiopharmaceuticals to treat cancer.