CHPM’s positive approval for 13 Medicines; NICE approval for AstraZeneca’s Olaparib; Exact Sciences to buy Genomic Health

CHMP opines positively for 13 Drugs for a variety of disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has endorsed the use of 13 medicinal drugs for a variety of indications. These include five new medications and eight existing ones whose use is extended to treat new indications. The new drugs to get approval include Epidyolex developed by GW Pharmaceuticals, Acorda Therapeutics’ Inbrija, Bayer’s Vitrakvi, Trogarzo of Theratechnologies and Mylan’s Deferasirox.  The other approved for expanding the indications are Tecentriq, Keytruda, E. mpliciti, Stelara, Lonsurf, Soliris, Zerbaxa and Lucentis.
Bayer’s Vitrakvi (larotrectinib), the first ‘histology-independent’ therapy in the European Union received conditional marketing authorisation for the treatment of solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The drug can be administered to both adult and paediatric patients whose tumour can not be operated with surgery. GW Pharmaceuticals’ also received the approval for its Epidiolex, which is a cannabidiol oral solution and is the first in its type. The drug is approved as an adjunctive Seizures treatment associated with forms of epilepsy namely Lennox-Gastaut syndrome or Dravet syndrome. Moving further, Acorda Therapeutics’ Inbrija (levodopa) received a nod for its use to ease the symptoms of ‘off’ periods in Parkinson’s disease and Theratechnologies’ Trogarzo (ibalizumab) in HIV infection treatment. Deferasirox, a product of Mylan laboratories, is an iron-chelating agent and generic medicine, which received a positive response in treating chronic iron overload in anaemia patients caused by blood transfusions.
Moreover, Roche’s Tecentriq, in a combination with chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults without EGFR mutant or ALK-positive disease and extensive-stage small cell lung cancer (ES-SCLC). Furthermore, Keytruda of Merck has been recommended to be used as first-line therapy for advanced renal cell carcinoma (RCC) in combination with axitinib. In addition, Merck’s also got approval for its Zerbaxa to be used in the treatment of complicated urinary tract infections, acute pyelonephritis, complicated intra‑abdominal infections and hospital-acquired pneumonia (HAP). Janssen Pharmaceutical’s Stelara and Bristol-Myers Squibb’s Empliciti have secured endorsement in moderate to severely active ulcerative colitis patients and in the treatment of relapsed and refractory multiple myeloma respectively. Novartis’ Lucentis for preterm infants with retinopathy of prematurity, Soliris of Alexion Pharmaceuticals’ for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults and Servier’s Lonsurf, for adult patients with metastatic gastric cancer, are some other drugs which received positive recommendations from EU CHMP.

AstraZeneca’s ground-breaking Ovarian cancer drug receives NICE approval

The National Institute for Health and Care Excellence (NICE) has approved AstraZeneca’s life-changing drug Olaparib (Lynparza) as a first-line treatment for Ovarian Cancer. Approval from NICE came after the recommendation of the drug for the same on National Health Service (NHS), England. The drug has been made available to women affected by a genetic form of cancer through Cancer Drug Funds.
Olaparib, which is a poly ADP-ribose polymerase (PARP) inhibitor, averts the repairing of damaged DNA present in the cancer cells, thus leading to the death of cells. The drug is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
The drug, presently, is used to treat advanced-stage Ovarian Cancer at later stages in patients who have received three rounds of chemotherapy already. Already in use, Olaparib ensures to benefit the most when administered at early stages and even promises to kill cancer from its root if given before the recurrence.
Ovarian cancer is the fifth most common type of cancer in women and the fourth most common cause of death in women. The estimated lifetime risk for a woman developing ovarian cancer is about 1 in 54. Besides Olaparib, Rubraca, a drug of Clovis Oncology and Doxil of Ortho Biotech are a few other available FDA-approved drugs in the Ovarian Cancer therapy market. While Rubraca is a poly (ADP-ribose) polymerase (PARP) inhibitor like Olaparib, Doxil is an anthracycline topoisomerase inhibitor specified for ovarian cancer treatment after platinum-based chemotherapy failure. Many biotech players and pharmaceuticals such as ImmunoVaccine Technologies, OncoQuest and Precigen are involved in taking forward Advanced Recurrent Ovarian Cancer Pipeline. DelveInsight estimates that the launch of potential emerging therapies such as PXSurvivac (ImmunoVaccine Technologies), Oregovomab (OncoQuest) and PRGN-3005 UltraCAR-T (Precigen) is expected to change the Ovarian cancer treatment landscape during the forecast period (2019-2028).

Exact Sciences to acquire Genomic Health in USD 2.8 Billion deal

Exact Sciences has decided to buy a fellow cancer technology firm Genomic Health for USD 2.8 Billion. The companies will merge in a cash-and-stock arrangement. The deal will be split in USD 1.1 Billion cash and the remaining USD 1.7 Billion stock with anticipated annual revenue of the combined entity to be around USD 1.6 Billion by the end of 2020.
The companies are planning to focus on breast cancer and prostate cancer detection along with accelerating the Exact Sciences’ existing colorectal cancer detection, Cologuard. Cologuard -stool-based cancer screening technology- since its launch has helped in identifying cancer in almost 2.6 million people. After the merger, Exact will have the diagnosis provision of around 40% of all the solid tumours.