CognitrexCancerDigest

Novartis has gained FDA approval for its PI3K inhibitor Piqray for advanced breast cancer, bucking the trend for the drug class in solid tumour therapy. The new drug is one of a clutch of 25 potential blockbusters Novartis hopes to launch in the next few years, and the first and only treatment to be approved by the FDA for patients with hormone receptor-positive, HER2- negative breast cancer with a PIK3CA mutation. The approval is for Piqray (alpelisib formerly BYL719) alongside fulvestrant, a combination that almost doubled progression-free survival (PFS) compared to fulvestrant alone in the SOLAR-1 study . The duo improved median PFS to 11 months compared to 5.7 months with fulvestrant alone in this patient group, and more doubled the overall response rate to 38% versus 16%. Its approval came on the same day as the FDA okay for Novartis’ gene therapy for rare disease spinal muscular atrophy (SMA) – Zolgensma – which is also predicted to be a future blockbuster. After the SO

Cancer drugs that speed onto the market based on encouraging preliminary studies often don't show clear benefits when more careful follow-up trials are done, according to research published Tuesday. These cancer drugs are granted accelerated approval to give patients faster access to the treatments and to allow drug companies to reap the economic rewards sooner. As a condition of this process, the Food and Drug Administration requires drug companies to conduct more research, to confirm whether the medications actually work and are safe. In 2018, the FDA looked back on 93 cancer drugs granted accelerated approval and touted that only five had been removed from the market over a 25-year span. A research team at Harvard Medical School's Program on Regulation, Therapeutics and Law dug deeper to see what had happened with the rest. In the follow-up studies, only 19 of the 93 drugs clearly extended the lives of the patients taking them, according to the study , published in

Officials with the FDA have approved alpelisib (Piqray, Novartis) tablets, to be used in combination with the endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. These tablets are the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer, according to Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment, and companion diagnostic tests assist oncologists in selecting patients who may benefit from these targeted tre

Merck on Tuesday agreed to buy Peloton Therapeutics for $1.05 billion in cash, gaining access to the privately held company’s lead kidney cancer drug candidate. The acquisition can strengthen Merck’s presence in the field of renal cell carcinoma and bolster its cancer drug portfolio. Merck’s blockbuster immunotherapy Keytruda was approved last month in the United States for treating renal cell cancer. “This is a classic bolt-on deal. Peloton has a drug that looks promising in renal cell carcinoma, and there’s actually been a lot of success in the field in recent years,” said Brad Loncar, who runs the Loncar Cancer Immunotherapy ETF. Peloton expects to start studying its lead drug, a kidney cancer treatment code named as “PT2977”, in a late-stage trial in the second half of this year. In an older mid-stage trial testing patients whose cancer had spread even after treatment with at least one therapy, 24% of patients treated with Peloton’s drug showed an at least 30% shrinkage o

Taking an important step to accelerate innovation of new multidisciplinary solutions to address the growing global cancer burden, Varian Medical Systems has announced that it has entered into a definitive agreement to acquire Cancer Treatment Services International (CTSI) for $283 million. Privately held, CTSI operates the American Oncology Institute in Hyderabad and 10 multidisciplinary—radiation, medical and surgical oncology— cancer centers across the Indian subcontinent as well as a U.S.-based Oncology Solutions division that provides cancer care professional services to healthcare providers worldwide. This transaction will accelerate identification of unmet clinical and operational needs to facilitate advances in technology and services. As a result, the combined companies will be positioned to create new multidisciplinary solutions based on robust clinical information benefiting oncologists, and ultimately resulting in better care for patients. These fast-growing offerings will

The Delhi High Court has restrained Hyderabad-based Natco Pharma from manufacturing fresh stock of drugs comprising of compound named 'Ceritinib' meant for treatment of non small cell lung cancer but allowed it to sell the existing stock keeping in the interest of the patient community. Justice Pratibha M Singh passed the order while directing Natco to file response to the injunction application moved by Swiss Pharma major Novartis which claimed to have been granted patent for Ceritinib which it said was a "novel and inventive compound" for treatment of non small cell lung cancer (NSCLC). Novartis claimed that the suit patent was filed as a Patent Convention Treaty application claiming priority since 2007, and was granted on 28th September, 2015. Novartis said it was forced to move court for injunction after it came across 'Ceritinib capsules' lanched by Natco under the mark NOXALK at a pharmaceutical conference at Kolkata on March 29. It informed the c

The Maximum Retail Price (MRP) of some cancer drugs has been slashed by the National Pharmaceutical Pricing Authority (NPPA) by up to 60 per cent. This is the second time since March that prices of some cancer drugs has been cut. In March, the rates were brought down for around 380 drugs, with some cuts going to as much as 80-90 per cent under trade margin rationalisation. According to NPPA, the prices of nine non-scheduled anti-cancer medicines were reduced by 30 to 60 per cent. Some of the drugs whose prices have been slashed are Erlotinab, Pemetrexed, Epirubician, Leuprolide acetat and Everolimus. These medicines treated different type of cancers including prostate and breast. This reduction in price comes as part of NPPA's focus on slashing of anti-cancer drugs prices. The VP of a cancer drug firm, however, told Hindu Business Line that that reduction announced by NPPA only sees marginal rationalisation at individual drug level. The reduction in price will cap the trade

Eli Lilly’s Cyramza has a new string to its bow after the FDA approved it as a second-line treatment for certain liver cancer patients, and received a further boost as the FDA removed a boxed warning from its label. The US regulator first approved Cyramza for cancer of the oesophagus in 2014, and since then Lilly has added further uses in gastric cancer after chemotherapy, an aggressive type of lung cancer, and as a second line treatment for colorectal cancer. With these approvals Cyramza has been a steady performer for Lilly, and generated $198.3 million for the Indianopolis-based pharma in the first quarter of 2019, up 8% year-on-year. The company will hope to build on this with the new indication in patients with hepatocellular carcinoma (HCC), who have alpha-fetoprotein (AFP) above 400ng/mL and have been treated with Bayer’s Nexavar (sorafenib). AFP is a prognostic biomarker that can be assessed through a simple blood test, allowing doctors to select patients who may bene

Independent experts on an advisory panel to the U.S. Food and Drug Administration on Tuesday voted against Daiichi Sankyo Co Ltd’s treatment for adults with a type of acute myeloid leukemia. The panel voted 8-3 against the drug, quizartinib, after assessing data presented by the Japanese company. Separately, an advisory committee voted 12-3 in favor of the approval of pexidartinib, another treatment from Daiichi, that aims to treat a type of rare, non-cancerous tumor usually affecting joints and limbs. Daiichi has been focusing on oncology, targeting 500 billion yen ($4.52 billion) in annual sales from the business in fiscal 2025 from 20 billion yen in 2017. Quizartinib is aimed at treating acute myeloid leukemia patients with a specific genetic mutation called FLT3. While several members of the panel acknowledged the drug did appear to bridge patients toward a transplant, which could potentially cure them, they said the data presented was not strong enough to support an approv

Novartis’s Sandoz division has struck a deal with Taiwan’s EirGenix Inc to market a biosimilar version of Roche’s Herceptin that is now in late-stage development to treat some cancer tumors. Novartis said the accord covers the trastuzumab biosimilar in Phase III development for human epidermal growth factor receptor 2 positive (HER2+) breast and gastric tumors. EirGenix will be responsible for development and manufacturing, while Sandoz has the right to commercialize the product in all markets except China and Taiwan. EirGenix will receive an upfront payment, milestone payments, and a share of profits from sales, Novartis said, giving no more financial details. The deal - the third biosimilar collaboration for Sandoz in 18 months - expands the existing Sandoz cancer portfolio of four oncology biosimilar medicines.