CognitrexCancerDigest

The Food and Drug Administration (FDA) has granted approval for Keytruda ® ( pembrolizumab ) to treat metastatic small cell lung cancer (SCLC). Pembrolizumab was approved as a third-line therapy for SCLC patients who still present disease progression despite current or past platinum-based chemo and at least one other prior line of therapy, according to the FDA. Keytruda is manufactured by Merck. “KEYTRUDA is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers,” said Jonathan Cheng, MD, vice president, oncology clinical research, Merck Research Laboratories, in a press release. “We look forward to continuing to advance important clinical research in small cell lung cancer.” “Small cell lung cancer, which accounts for 10 to 15% of all lung cancers, is often diagnosed at an advanced stage where the...

GlaxoSmithKline plc announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for Zejula (niraparib). The application was granted priority review and has an action date of 24 October 2019. The sNDA supports a potential new indication for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with either: BRCA mutation or homologous recombination deficiency (HRD) and have progressed more than six months after the last platinum-based chemotherapy. Mary Lynne Hedley, Ph.D., president and chief operating officer of Tesaro, said, “The results of the QUADRA study demonstrate that Zejula is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ov...

The Bengaluru-based Esperer BioResearch has urged the Union government to introduce a nutritional therapy programme in the national cancer control programme as it will enable a longer survival of patients with higher quality of life. The company's plea is based on the that globally oncologists have a rigorous nutritional evaluation for the early detected cancer patients to gauge their body’s ability to withstand toxicity of drugs. The company now wanted the Indian oncologists also to ascertain the nutritional status of patients before they prescribe a cancer therapy. This is because malnourished patients are seen to increasingly succumb to the disease faster. The company has initiated talks with the Union government to adopt the nutritional therapy programme during its cancer detection programme and endorse its supplements. The company’s six-year long research led to development of two products to combat nutritional deficiency in cancer patients. The first is Es-Fortitude whi...

Pfizer Inc. ( PFE ) today announced that the European Commission approved TALZENNA®(talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.1 This approval follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018. “Today’s approval of TALZENNA for certain patients with advanced-stage breast cancer and an inherited BRCA m...

New York: US pharmaceutical giant Pfizer on Monday announced the acquisition of Array BioPharma, a biotechnology firm that specializes in cancer drugs, the latest in a long list of biotech mergers in recent years. In a statement, Pfizer said it offered $48 per share in cash for Array, putting an $11.4 billion value on the company. "The board of directors of both companies have approved the merger," Pfizer said. The proposed acquisition "sets the stage to create a potentially industry-leading franchise for colorectal cancer alongside Pfizer's existing expertise in breast and prostate cancers," Pfizer CEO Albert Bourla said. Array's portfolio includes two drugs, Braftovi (encorafenib) and Mektovi (binimetinib), that when combined are effective in treating BRAF-mutant melanoma. The combination of the two drugs was authorized in September by the European Commission, several months after the US Federal Drug Administration gave its approval. Besides melanomas...

A class of drugs is emerging that can attack cancer cells in the body without damaging surrounding healthy ones. They have the potential to replace chemotherapy and its disruptive side effects, reshaping the future of cancer care. The complex biological medicines, called antibody drug conjugates (ADCs), have been in development for decades, and are now generating renewed excitement because of the success of one ADC in late-stage testing, a breast cancer treatment called DS-8201. The fervor over ADCs is such that AstraZeneca Plc in March agreed to pay as much as $6.9 billion to jointly develop DS-8201 with Japan’s Daiichi Sankyo Co., the British drugmaker’s biggest deal in more than a decade. The investment was widely seen to be a validation of DS-8201’s potential -- and the ADC class of drugs as a whole -- as an alternative for chemotherapy, the most widely used treatment, for some types of cancer. DS-8201, which will be filed for U.S. approval by the end of September, is so we...

KEYNOTE-062 shows that front-line pembrolizumab may be promising alternative to chemotherapy The results of KEYNOTE-062 randomised phase III trial were presented at 2019 ASCO Annual Meeting by Dr Josep Tabernero of Vall d’Hebron University Hospital and Institute of Oncology, Barcelona, Spain. Dr Tabernero told delegates that the study achieved its primary endpoint, showing that for patients with PD-L1-positive, HER2-negative, advanced gastric or gastro-oesophageal junction cancer, front-line therapy with pembrolizumab resulted in non-inferior overall survival (OS) when compared to standard chemotherapy. Pembrolizumab showed clinically meaningful improvement in OS among patients with tumours that had high levels of PD-L1 expression. The study also evaluated combined treatment with pembrolizumab and standard chemotherapy, but this regimen did not improve survival relative to chemotherapy alone. The KEYNOTE062 (NCT02494583) was a randomised, active controlled study of first-line pembroli...

Merck & Co Inc said on Tuesday its blockbuster cancer drug Keytruda won approval from the U.S. Food and Drug Administration to treat a type of head and neck cancer. The drug was approved for use as a monotherapy, as well as in combination with a common chemotherapy regimen, to treat previously untreated patients with head and neck squamous cell carcinoma, Merck said. The approval is based on results from a late-stage trial, where Keytruda showed a significant improvement in overall survival in cancer patients, Merck said. Keytruda, a type of immunotherapy called a PD-1 inhibitor, is already an approved treatment for several forms of cancer, including lung and skin cancers. Head and neck cancer includes tumors in the mouth, tongue, nose, sinuses, throat and lymph nodes in the neck. Merck estimates that there will be more than 65,000 new cases of head and neck cancer diagnosed in 2019 in the United States. Keytruda works by increasing the ability of patients’ immune syst...

The Janssen Pharmaceutical Companies of Johnson & Johnson have announced the latest research to be presented at the 24th European Hematology Association (EHA) Annual Congress taking place in Amsterdam, The Netherlands, from 13“16 June 2019. Janssen will present 28 company-sponsored abstracts from its leading haematological malignancy portfolio at the congress, including the latest results for DARZALEX (daratumumab) and IMBRUVICA (ibrutinib). With more than 11,000 attendees, EHA is the premier congress for the latest innovations in haematology in Europe and Janssen is proud to be presenting important data from our clinical development programmes, said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA) Haematology Therapeutic Area Lead, Janssen-Cilag France. We are committed to changing outcomes and improving options for patients diagnosed with cancer. Therefore, we are pleased to present results from the daratumumab CASSIOPEIA study, which has been selected for inclusion i...

The US Food and Drug Administration (FDA) approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomised (1:1) to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab. In AUGMENT, the primary endpoint was progression-free survival (PFS) in the intent-to-treat population, as determined by an independent review committee (IRC). Median PFS was 39.4 months (95% CI: 22.9, NE) in the lenalidomide arm and 14.1 months (95% CI: 11.4, 16.7) in the placebo-containing arm (HR 0.46; 95% CI: 0.34, 0.62; p < 0.0001). The o...

(Reuters) - AstraZeneca Plc said on Thursday its blood cancer drug met the main goal of a final stage trial, taking the treatment one step closer to a marketing approval as the drugmaker seeks to bolster its oncology portfolio. In its second late-stage trial success in a month, the drug showed meaningful improvement in patients with chronic lymphocytic leukemia when compared with a chemotherapy-based treatment, the company said. The drug, Calquence, is a cornerstone product for AstraZeneca in haematology and its accelerated U.S. approval in 2017 marked its first entry into blood cancer treatment. “The positive results from both the ... trials will serve as the foundation for regulatory submissions later this year,” said R&D José Baselga, executive vice president of the company’s oncology division. The drug, which is already approved by the U.S. drug regulator to treat a rare type of blood cancer, met the primary endpoint in a trial in May testing the drug in comparison with availa...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today findings from the investigational Phase 3 TITAN study, which showed the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) compared with placebo plus ADT significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).1 The study included patients with mHSPC regardless of extent of disease or prior docetaxel treatment history.1 Results were presented in an oral session at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago ( Abstract #5006 ), and simultaneously published online in The New England Journal of Medicine . The data were selected for Best of ASCO 2019 Meetings , which highlight cutting-edge science and reflect leading research in oncology. Apalutamide plus ADT significantly extended OS compared to placebo plus ADT with a 33...